Quality Assurance Director Resume Samples

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TH
T Hane
Telly
Hane
15528 Adriel Parkway
New York
NY
+1 (555) 560 3268
15528 Adriel Parkway
New York
NY
Phone
p +1 (555) 560 3268
Experience Experience
New York, NY
Quality Assurance Director
New York, NY
O'Conner, Homenick and Green
New York, NY
Quality Assurance Director
  • Performing end-to-end testing life cycle governance for QA and assisting Project Managers and India leadership in planning and executing Book Of Work (BOW)
  • Oversees training and development of partners directly and indirectly managed and makes effective staffing decisions
  • Assist account managers/client partner in related business development activities to grow mindshare and market share in the account
  • Collects, analyzes, and manages real-time performance improvement data
  • Leads quality system Management Reviews and serves as Quality Management Representative at various venues
  • Works independently to manage the whole program and respective stakeholders/ and projects
  • Get first-hand customer information and uses it for improvements in services provided by Cognizant
Philadelphia, PA
Director of Quality Assurance
Philadelphia, PA
Hegmann-Bernier
Philadelphia, PA
Director of Quality Assurance
  • Responsible for all aspects of regulatory compliance including FDA and DEA regulations
  • Responsible for responses to client audit and regulatory observations
  • Implement and monitor the Quality Management System (QMS)
  • Develop and implement site specific quality assurance policies and procedures
  • Conduct internal, client, vendor, and regulatory audits
  • Manage the QA department
  • Has authority for all personnel actions
present
San Francisco, CA
Senior Director of Quality Assurance
San Francisco, CA
Smitham LLC
present
San Francisco, CA
Senior Director of Quality Assurance
present
  • You'll collaborate with Development, Implementation, and Operations teams to establish quality throughout the organization
  • You will prioritize, handle, and execute multiple tasks, define problems, and resolve issues with limited supervision from senior management
  • Tracking information about customer complaints to provide design, development and operations teams with product quality information
  • Reviewing performance of Quality Assurance staff in achieving compliance and system improvement objectives
  • Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations
  • Oversee qualification, performance tracking, and reviews of contract manufacturers and laboratories and manage internal and external audits
  • You'll be responsible for the hands-on, daily management of 8-10 direct report staff workload
Education Education
Bachelor’s Degree in Computer Science
Bachelor’s Degree in Computer Science
West Virginia University
Bachelor’s Degree in Computer Science
Skills Skills
  • Capable of performing the functions and be knowledgeable of aviation ground safety and management
  • Directs and oversees the work of quality professionals supporting manufacturing and design assurance
  • Strong communication skills to be able to communicate at all levels
  • Ability to manage others
  • Develops and implements quality strategy and objectives
  • Develops and implements quality planning, inspection methods and defect prevention/corrective action processes for new and existing products
  • Good analytical skills in order to aid in trouble shooting and problem solving
  • Legal ability to travel internationally
  • History of interacting with suppliers and sub-contractors in a production environment for the purpose quality control
  • Good leadership skills in influencing across job families
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15 Quality Assurance Director resume templates

1

Quality Assurance Director Resume Examples & Samples

  • Managing across multiple QA teams and a COE
  • Managing executive stakeholder relationship and cross LOB engagements
  • Utilizing a suite of testing tools that includes Quality Center, Quick Test Pro, etc
  • Performing end-to-end testing life cycle governance for cross-LOB QA andassistingProject Managers and offshore leadership in planning and executing Book Of Work (BOW)
  • Managing resource capacity and demand in sync with BOW
  • Providing coaching and mentoring to less experienced team members
  • Researching and evaluating alternative solutions to QA methodologyand making recommendations
  • Developing efficiencies and ways to improve testing processes
  • 10 years of software testing experience
  • Demonstrated expertise using automated testing tools including Quality Center, Quick Test Pro, etc
  • Demonstrated proactive approach to problem solving
  • Good leadership skills in influencing across job families
  • High level of responsibility and ownership from inception through to implementation
  • Good analytical skills in order to aid in trouble shooting and problem solving
2

Aml Quality Assurance Director Resume Examples & Samples

  • Professional experience in an Anti-Money Laundering group at a large financial institution
  • Be degree educated or equivalent (with outstanding academic credentials)
  • ACAMS certified or an equivalent qualification
  • Experience in resolution of surveillance items flagged as potentially suspicious
  • The ability to critically review closure rationale to determine if the resolution was appropriate and appropriately documented
  • The ability to identify solutions for recurring issues identified during the QA process
  • Excellent time management skills and ability to execute tasks within tight deadlines
  • Excellent analytical, oral and written communication skills
  • Have excellent interpersonal skills necessary to work effectively with colleagues across regions and business units
  • The ability to research and resolve issues independently while working across teams to acquire information
  • Self-motivation and will be a team player
3

Director of Quality Assurance Resume Examples & Samples

  • 10+ years of relevant industry experience; 5+ years of Managerial-related experience in the Pharmaceutical Industry
  • Extensive knowledge of quality management techniques and systems
  • GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria
  • Highly organized
4

Director of Quality Assurance Resume Examples & Samples

  • RN, BSN
  • 5+ years of supervisory experience
  • Success in obtaining NCQA accreditation
5

Director of Quality Assurance Resume Examples & Samples

  • Bachelor’s or master’s degree in accounting, finance, business administration, or equivalent
  • 7+ years of experience in internal audit, assurance advisory, public accounting (financial services or banking or capital markets industry experience is preferred)
  • Internal audit, assurance, or accounting professional certification (CIA, CPA, CISA or equivalent) required
  • Experience in internal audit, assurance advisory, or public accounting quality assurance review function desired, but not required
  • Knowledge and appreciation of regulatory, accounting, and financial industry guidance and best practices relevant to the business, including technology implications
  • Knowledge and experience in control theory and professional audit practices required, including the assessment of inherent risk, evaluation of control design, development and execution of audit tests and the assessment of control deficiencies
  • Knowledge of the Institute of Internal Auditors International Professional Practices Framework (IPPF) and understanding of other regulatory standards for the internal audit professional
  • Proficiency in Microsoft Office and experience in use of automated audit/assurance documentation systems
  • Assist VP in development and execution of the department’s quality assurance program
  • Oversee the tracking, monitoring, and end-to-end management of corrective action plans associated with QA reviews
  • Support internal and external assessments of the internal audit function, including facilitating pre-planning and readiness reviews
  • Identify improvement opportunities and best practices based on results of quality assurance reviews
  • Partner with audit methodology and professional development team to design and deliver audit-related training program components to diverse groups of auditors with varying levels of experience based on QA results
  • Manage external benchmarking activities and maintain awareness of current, best-in-class internal audit practices
6

Director of Quality Assurance Resume Examples & Samples

  • 7+ years of experience in Internal Audit, Assurance advisory, and/or Public Accounting
  • College Degree or Advanced Degree in Accounting, Finance, Business administration and/or related field
  • Internal Audit, Assurance, or Accounting professional certification (CIA, CPA, CISA or equivalent)
  • Knowledge and appreciation of Regulatory, Accounting, and Financial industry guidance and best practices relevant to the business, including technology implications
  • Knowledge and experience in control theory and professional audit practices required including the assessment of inherent risk, evaluation of control design, development and execution of audit tests and the assessment of control deficiencies
  • Knowledge of the Institute of Internal Auditors Professional Practices Framework and understanding of other regulatory standards for the internal audit professional
  • Financial services and Banking/Capital Markets industry experience
  • Experience in Internal Audit, assurance advisory, or public accounting quality assurance review function
7

Director, Audit Quality Assurance Resume Examples & Samples

  • Delivery of services in accordance with the Department's policies and procedures
  • Partnering with the Department's business, product and technology audit teams as needed
  • Establish and maintain ongoing relationships with headquarters, business and functional leadership for the subject areas
  • Create, manage and maintain a high performing team of domain experts and provide effective coaching and team member development for both in-house and co-sourced resources
  • Certified Internal Auditor (CIA), Certified Information Systems Auditor (CISA), Certified Public Accountant (CPA) or related certification preferred
  • Bachelor's degree and 12 years of relevant experience or High School/GED and 16 years relevant experience
  • MBA or equivalent preferred
  • Deep understanding of internal audit best practices, IIA standards, relevant regulatory requirements for the subject areas and past experience working with regulatory bodies (e.g., Fed, OCC, etc.)
  • Strong knowledge of business line processes, risks and controls for Commercial Lending and Leasing including Structured Finance and Corporate Finance
  • Fluent (speak, read and write) in English and local language
  • Must be willing to 30% of the time
  • Must apply via COS (internals) or through www.gecareers.com (externals) to be considered for this position
  • Candidates must have effective negotiation skills, a proactive and straightforward approach in communicating issues and strength in sustaining independent views
  • Previous experience working with local external regulators and risk and control thought leaders
  • Strong understanding of internal audit industry leading practices within the subject areas and the ability to apply them within the GEC organization
  • Ability to challenge internal audit professionals and influence positive change within internal audit
  • Ability to build strong trusting relationships with senior business stakeholders
  • Ability to suggest and implement policy changes to key internal audit stakeholders that will improve the overall quality program
  • Proven ability to direct personnel across multiple locations and operations and work in a matrix-type organization; proven ability to lead teams
  • Possess strong project management skills, make sound decisions, and exhibit initiative and intuitive thinking. Consulted often by others for advice and opinions and recognized as a leadership role model; and,
  • Strong oral and written communication, presentation and facilitation skills
  • Experience conducting Treasury and Risk related reviews
8

Quality Assurance Director, Risk Resume Examples & Samples

  • Partner with the IA Risk team, particularly with the Risk Chief Auditor and their direct reports
  • Reports to the Chief Auditor Strategy & Quality Assurance to carry out independent QA reviews of assurance work performed by internal auditors including Hot Reviews, Site Reviews, moderating cold review scorecards and Thematic Reviews
  • Assisting in the review and improvement of global IA methodology and practices through
  • Drafting and presenting methodology documents, guidance notes and practice guides
  • Developing and rolling out methodology training that are subject matter relevant to Risk and to take into account of current industry practice
  • Providing day to day support and guidance to the Risk IA team on methodology-related matters
  • Share industry knowledge, best practice, near misses experience from previous auditing background, transfer knowledge to Risk auditors via report review, QA Forum, hot reviews, lunch & learn sessions and bite-size training
  • Perform risk based Hot Reviews during live audits. Subject matter check and challenge, methodology adherence and understand auditors’ rationale and application of auditor judgment
  • QA of IA Risk’s completed risk assessment, Quarterly Refresh as part of Quarterly Business Monitoring again using industry knowledge
  • QA of IA Risk’s presentations for Regulators, Audit Committees, Risk Committees and other management committee reporting
  • Conduct Site Reviews (IA sites around the world to test IA standards and compliance with Group and local policies) using the QA testing strategy, i.e., develop and maintain the audit universe, risk assessment; incorporating scorecard results, thematic review results
  • Lead QA Thematic Reviews
  • Working with the QA team to develop a methodology to provide a valued interactive program of support and assurance to subsidiary boards and audit committees, as appropriate, on issues, trends, root causes and impacts to the respective business activities and the group
  • Working with the QA team to develop a methodology to provide a valued interactive program of support and assurance to senior management on issues, trends, root causes and impacts to the respective business activities and the group
  • Working with the QA team to develop a methodology to provide a valued interactive program of support and assurance in accordance with requirements and appropriate expectations to regulators and supervisors on issues, trends, root causes and impacts relating to governance, risk management and internal control issues
  • Working with the QA team to develop a valued interactive program of support and assurance covering the assessment and reporting of key risks across businesses and products, legal entities and jurisdictions, providing stakeholders with insight and practical solutions to improve the control culture and environment across Citigroup
  • Use QA scorecards for compliance with IA Methodology to identify root cause, trends, and impact on IA’s adherence to regulation in the respective jurisdictions in which Citi and IA operate
  • Participate in Risk IA team meetings and share best practice, common pitfalls identified from Scorecards, Site Reviews and Thematic Reviews
  • Develop an approach to promote knowledge sharing and promulgation of best practices across IA and Citi
  • Developing innovative and creative ideas which promote medium and long term improvement in audit practices, QA and IA operations (including finance, human resources, communications and infrastructure support)
  • Build relationships with Citi’s regulators
  • Candidates should have 15 plus years of diversified risk management experience, ideally including experience in audit or a related field. Experience of working in a global organization is desirable
  • Must have first-hand audit experience of risk management in a top tier investment bank covering at least one of the following disciplines in detail: credit, market, model and operational risk management. Knowledge and competency of one or more these disciplines is desirable
  • Have in-depth knowledge and practical experience of the adoption of best practice risk and compliance strategies as embodied in Basel and other international best practice in one or more Core Regulatory College countries (i.e., US, UK, Singapore, Hong Kong, Japan and/or Mexico)
  • Experience in working with international operations and teams. He/She should have a thorough knowledge of operations and control systems as well as an understanding of best-in-class audit methodologies. H/She must be proficient in risk and control analysis and audit concepts for a full range of products and specialized areas and will be skilled at analyzing root causes of problems and anticipating ‘horizon’ issues. Related certifications
9

Director of Quality Assurance Resume Examples & Samples

  • 12+ years of Risk Management Audit experience
  • Previous experience with Credit, Market, Model and/or Operational Risk Management
  • Solid Internal Controls background
10

Associate Quality Assurance Director Resume Examples & Samples

  • 30% Product Quality Strategy and CMC: Responsibility for Product Quality Strategy and ensuring appropriate Quality Representation on CMC meetings
  • 30% Regulatory Submissions: responsibility includes ensuring appropriate quality review of regulatory submissions (i.e. filings, annual reports, responses to questions, progress reports for regulatory commitments), ensuring submissions are in line with the strategy set, and verifying regulatory submissions for accuracy/data integrity
  • 20% Due Diligence and Integration: Provide both strategic and tactical quality input into New Product integration, New platform implementation and New acquisition for the assigned Business unit
  • 10% Tactical Product Quality/ Compliance Governance: Maintain oversight for Business unit product performance and as needed
  • Facilitate other Quality related activities in collaboration with their CMC teams
  • Ensure appropriate escalation to Senior Management of significant quality or regulatory issues that may impact patient safety, product quality, supply or regulatory compliance
  • 10% Leadership
  • PhD degree in Chemistry/Biology, or relevant scientific/engineering discipline with 7-10 years of industry experience; or MS or Bachelor’s degree with at least 10 years industry experience
11

Manufacturing & Quality Assurance Director Resume Examples & Samples

  • Establish and implement quality assurance procedures for TOMS globally
  • Create and execute processes to monitor TOMS’ production quality. Early detection of quality issues is a priority of these processes
  • Analyze data (for example: from production reject rate and from customer service returns) to quantify QA/QC issues
  • Analyze data to define and clarify product quality problems. Subsequently, create and execute solutions
  • “ Troubleshoot” QA/QC problems—identify the root cause of a production QA/QC problem and implement a solution
  • Support TOMS product development, especially with regards to product launches and product upgrades—create and implement test procedures to mitigate risk of product failure and maintain TOMS’ high quality and fit/comfort standards
  • Manage TOMS’ fit and wear testing programs
  • Advanced experience preferably in development, commercialization, manufacture of footwear, apparel, or accessories with leading multinational companies
  • Relevant experience in lean manufacturing, Six Sigma, or similar discipline would be an advantage
  • Leadership and ability to achieve aggressive company goals and highest standards in the agreed timelines
  • Undisputed integrity, personal, and business ethics; ability to build trust and respect with different stakeholder groups
  • Ability to work in a lean, fast-paced/changing environment, highly collaborative, multi-national teams, and must be comfortable with and embrace consensus decision-making
  • Bachelor’s degree in business or engineering
  • Master’s degree preferred in business or engineering
  • In line of education, 10-15 years of QA / QC experience in the footwear industry is required
  • Accessory and apparel experience is a plus
  • Fluent in oral and written English
  • P roficient with computer skills i.e. Microsoft Office, SAP, etc
12

Director Global Brand Quality Assurance Resume Examples & Samples

  • Build and sustain a QA to Brand and Brand to QA partnering relationship. Learn and understand the Brand's mission, values and consumer requirements and in collaboration with the Brand build the quality design and execution into the Brand. Establish the method and means to track performance and develop objective goals
  • Actively participate in the C2M process (concept/design, development, 1st production and distribution phases of product launches via "Right First Time" stage gate meetings or Brand specific commercialization processes to ensure a successful launch. Work closely with the QALT, GBSC, GSR, Product Development and R&D to ensure that appropriate product quality requirements are established and implemented
  • Lead the communication of quality problem notification/resolution to the Brand and vice versa. Actively pursue timely response and final preventive resolution to quality issues working with the QALT and functional partners. Active participant/co leads GCC monthly meetings
  • Participate in product line reviews and standards management. Participate in the supplier performance tracking program (GQMS) and in the supplier excellence program. Share "best practices" resolutions globally across brands and regions as a key part of the fragrance category lead responsibly
  • Active member of the QALT, participate in staff/brand lead meetings, contribute to the global QA strategy/objectives
  • BS/MS in science or engineering (chemistry, pharmacy, or food technology preferred) or equivalent through experience and additional training. Additional formal training in Quality Management a plus
  • Minimum 8 years experience in managerial positions, preferable in Quality Assurance, in consumer goods (cosmetics, packaged goods, food or pharmaceuticals)
  • Experienced in the use of quality tools with a sound statistical base: Quality Management systems, process mapping, tooling qualification, FMEA and others. Knowledge of packaging manufacturing processes is a plus
  • Computer literate with good working knowledge of Microsoft products. (SAP knowledge an added advantage)
  • Demonstrated success in handling multiple cross-functional projects
  • Demonstrated communication, leadership and human relations skills - able to work well with all elements within and outside of the organization
13

Healthcare Quality Assurance Director Resume Examples & Samples

  • Three or more years of Healthcare experience, preferably with Medicaid, including managed care organization experience
  • At least three years managing QA & Corrective Action programs
  • At least two years’ experience analyzing performance metrics & conducting trend analysis
  • Three or more years’ experience developing and implementing a Testing Strategy and Test Plan for large scale development projects, preferably in a healthcare environment
  • Demonstrated ability to communicate effectively, orally and in writing, with all levels of management
  • At least five years managing business QA functions
  • At least five years managing corrective action programs
  • Quality auditor certification, such as ISO 9001, NQA-1 or ASQ
  • Knowledge and experience with IEEE standards related to testing
  • Three or more years in the QA function of a large-scale claims processing organization
  • Six sigma is preferred
  • This is a REMOTE role, but should be in close proximity to our West Sacramento office as some on site work will be required periodically
14

Quality Assurance Director Resume Examples & Samples

  • Establishes annual Quality goals and objectives
  • Manages QA department resources so that business objectives are cooperatively supported without sacrificing product quality principles
  • Develops the quality department budget and capital budget
  • Execute the business plan within budget and look for opportunities to improve the efficiency of the group
  • Oversees the development, management and communication of quality metrics, trends or root cause analysis that will contribute to improvements minimizing or eliminating re-occurrence
  • Review and approve as necessary batch records, documentation for use in manufacturing, packaging, testing and disposition of products
  • Develop and maintain the Quality System Manual in compliance with requirements of FDA and internal QA index (GMP’s) requirements/guidelines
  • Serves as the primary site contact for Regulatory visits such as FDA. Responds to inspectional observations and any enforcement activities required
  • Provides regulatory and compliance expertise and interpretation to personnel in situations requiring such expertise
  • Oversee the GMP audit program and make recommendations for corrective actions to maintain compliance with federal and state agencies
  • Works with contract manufacturers/packagers to resolve quality issues
  • Elevate any major issues to Factory Manager and QA Corporate (VP QA and Corporate QA Director)
  • Directs document control for all OTC functions, manufacturing documentation and SOPs, GMP training, and reports to FDA and other federal and state agencies
  • Works closely with NPD (New Product Development), PCD (Product Concept Development), TPD (Technical Packaging Development) and R&D teams to put QA into Design (FMEA)
  • Takes an active role in qualification of OPI’s contracted manufacturers
  • Oversees package compatibility and stability testing and approval
  • Maintains a clear understanding and working knowledge of GMP requirements, Safety requirements, and SOP’s
  • Adheres to and enforces those policies within the team
  • Additional tasks, duties and/or responsibilities as assigned by management
  • Bachelor’s degree in Life Sciences discipline or other technical degree (i.e. Business, Chemistry, Biology, or Engineer etc.)
  • 5+ years of managerial experience in Quality in the manufacture of Cosmetics, Skin care or related products
  • Progressive career history in the development and implementation of quality systems with oversight of QA, QC, validation, product release, CAPA and problem solving
  • Strong working knowledge of GMPs and/or FDA/ISO guidelines for manufacturing of Cosmetic and related products
  • Strong analytical and organizational skills with the ability to identify issues and generate solutions
  • Proficient in Microsoft Office (Word, Excel, Access and Outlook) and the ability to use an ERP warehouse management system
  • Ability to drive change and develop talent
  • Well developed decision making skills and results oriented
  • Ability to be flexible, multi-task, have strong organizational, communication and leadership skills to meet strict deadlines and manage multiple projects simultaneously in a fast paced environment
15

Quality Assurance Director Resume Examples & Samples

  • Develops Healthcare QA program implementation plans & procedures across Business Operations
  • Establishes and manages Corrective Action Program implementation
  • Directs staff day-to-day QA implementation activities
  • Manages scheduling, coordination & execution of QA related activities
  • Conducts QA audits of development, testing, design changes, implementation & operations
  • Conducts QA reviews to verify compliance with contract requirements & standards
  • Oversees all phases & iterations of risk management, testing & defect resolution
  • Serve as liaison with state officials coordinating quality audits & reviews as necessary
  • Interprets quality requirements & standards
  • Oversees continuous improvement implementation Required Skills · Three or more years of Healthcare experience, preferably with Medicaid · Bachelor’s degree · At least three years managing QA & Corrective Action programs · At least two years’ experience analyzing performance metrics & conducting trend analysis · Demonstrated ability to communicate effectively, orally and in writing, with all levels of management Preferred Skills · At least five years managing business QA functions · At least five years managing corrective action programs · Quality auditor certification, such as ISO 9001, NQA-1 or ASQ · Three or more years in the QA function of a large-scale claims processing organization · Two or more years in call center operations managed to meet inbound and outbound call level · Six sigma is preferred
16

Quality Assurance Director Resume Examples & Samples

  • Supports the implementation of Company programs, procedures, methods and practices to promote Starbucks key messages and achieve a competitive advantage
  • Assures compliance to quality and product safety standards from source of supply to consumer
  • Develops an integrated quality assurance program and budget covering beverage, food, merchandise, product distribution channels and retail facilities
  • Manages quality assurance projects and supervises partners
  • Progressive experience managing a research and development or quality assurance department
  • Motivation skills
  • Ability to apply sound business principles and practices to project management and change management processes
17

Quality Assurance Director Resume Examples & Samples

  • Lead and Manage India QA teams in alignment to global QA goals
  • Responsible for resource planning, allocation, evolving efficiency and maturity of India teams both at GSC and Vendor ODCs to deliver across various LOB Book of Work commitments
  • Accountable for optimal utilization of Test Automation Service, partnering with Automation Lead and LoB aligned CQOs on automation business cases and ROIs
  • Performing end-to-end testing life cycle governance for QA and assisting Project Managers and India leadership in planning and executing Book Of Work (BOW)
  • Researching and evaluating alternative solutions to traditional QA methodology and making recommendations
  • Developing efficiencies and ways to improve testing processes and quality across the SDLC
  • Represent India QA capability at CCB CQO and India CIO tables
  • (8-10+) years of Senior Level Management experience, providing Leadership to drive improved methodologies ensuring low cost, high quality support methodologies to deliver quality across the lifecycle
  • Experience with the development of successful quality control procedures and QA programs
  • 10+ years of hands on software testing experience
  • Deep experience of setting up and management of large QA capability, pref for Consumer Banks
  • Detailed understanding of relevant technologies, various development lifecycles and quality assurance phases
  • 5+ years recent experience managing teams within a Shared Service and/or Center of Excellence Model
  • Solid understanding of systems analysis, programming and operations
18

Director of Quality Assurance & Change Management Resume Examples & Samples

  • Responsible for development and application of control frameworks around (1) routine financial deliverables, (2) ad-hoc financial deliverables, and (3) change management around new or changed business activities
  • Ensure accounting and reporting controls are properly designed, including ownership around process maps and control documentation, and are operating as designed
  • Review, investigate, and assess errors and inconsistencies in financial documents and reports to assess whether control breakdowns have occurred
  • Development of metrics and meaningful reporting to senior management around control framework compliance
  • Create culture to propel meaningful process changes or improvements to increase efficiency, maintain credibility, and to continue to meet needs in an ever-changing business and regulatory environment
  • Lead the department's talent related practices including performance management, training and development, personnel changes and related items
  • Evaluate current control practices and policies and drives continuous improvement
  • Four-year college degree with an emphasis or major in Accounting, Finance or related field of study or equivalent work experience
  • 10+ years of professional experience with progressive levels of responsibility in the financial service industry. Significant experience with auditing, SOX, and financial reporting is essential
  • Prior supervisory/managerial experience
  • Experience executing financial reporting and accounting control frameworks
  • Experience working directly with executives
  • Advanced analytical skills
  • Proven track record of building relationships in a 360 manner to gain influence across an organization,
  • Proven track record of building relationships to gain influence across an organization
  • Manage a team of contractors and/or staff
19

Director, Global Quality Assurance Resume Examples & Samples

  • Lead the overall management of the global Quality audit program, including: internal EL manufacturing and distribution sites, 3rd party, and supplier audits
  • Lead and manage a staff of 6 internal quality auditors who conduct audits and oversee audits/reports conducted by outside auditing agencies
  • Ensure that audits are conducted according to EL policy, that every audit has a timely audit report issued, and that corrective action/preventative action (CAPA) plans are identified for every audit
  • Implement and maintain databases for: audit scores, non-conformances and repeat non-conformances, such that continuous improvement can be objectively driven towards higher performance
  • Administer auditor training and calibration programs for consistency and standardization of audit practices
  • Implement, maintain and share a Community of Practice database for global application of best practice CAPA solutions derived from audit experience
  • In addition to managing the global Quality audit program, also personally conduct quality audits per the corporate audit schedule
  • Assure that existing and new corporate EL policies/procedures are integrated into quality audit inspections to ensure global compliance
  • Maintain a regulatory agency inspection nonconformance database
  • Be knowledgeable in and stay current in regulations pertaining to the personal care industry; e.g. OTC GMPs, dietary supplement GMPs, food GMPs, EU GMPs, etc. Act as an expert resource regarding regulatory GMP questions globally
  • Manage and administer the QA OTC complaint handling response investigation process according to policy/procedure and ensure that complaints are handled efficiently and timely
20

Claims Quality Assurance Director Resume Examples & Samples

  • Notify underwriters and team leaders of highly significant losses and/or claims
  • Coordinate the claims servicing of all accounts in accordance with client and carrier claim handling expectations and professional standards
  • Gather and review loss information and prepare claim summaries and exhibits for periodic claim review meetings with TPA, program team and industry associations, if applicable
  • Coordinate and conduct semi-annual claim review meetings with TPA and program team
  • Review and analyze client/program loss information to determine loss trends and other claims-related or loss control issues
  • Provide analysis, interpretation and recommendations to the underwriting team and management regarding individual client loss information and/or the overall program
  • Identify loss leaders in the program and work with underwriting to develop action plan to change results
  • Review and analyze coverage and exposure questions from the TPA
  • Monitor the performance of carriers/TPAs, acting as liaison between carriers/TPAs and underwriting, addressing service issues and documenting service issues to senior management as appropriate. This includes timeliness of claims handling, monitoring of reserves and verifying data integrity
  • Develop and grow relationships with insureds, brokers, carriers and TPAs
21

Director of Quality Assurance Resume Examples & Samples

  • Responsible for all aspects of regulatory compliance including FDA and DEA regulations
  • Implement and monitor the Quality Management System (QMS)
  • Develop and implement site specific quality assurance policies and procedures
  • Manage the QA department
  • Has authority for all personnel actions
  • Direct and coordinate activities of all QA operations to maximize quality, customer satisfaction, regulatory compliance, project timelines, productivity, and profitability
  • Member of the QMT, with responsibility for assigning and monitoring all CAPA activities
  • Demonstrate expertise with variety concepts, practices, and procedures
  • May provide consultation on complex projects and is considered to be the top level contributor/specialist
  • Typically reports to senior management
  • Responsible for employee career development and retention
  • Has annual and capital budget responsibility
  • Knowledge of analytical chemistry, demonstrated through
  • BA/BS in Chemistry, Biology or related scientific degree
  • 7-15 years of related industry experience in an analytical laboratory
  • Organization, communication and analytical skills
  • Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors
  • Intermediate mathematical skills, including: algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators
22

Quality Assurance Director Resume Examples & Samples

  • Oversee a strong global quality team by hiring and developing strong quality managers, establishing and actively managing performance expectations, and providing training opportunities to staff
  • Coach, motivate, and communicate to a mix of RUO (ISO 9001), CE-IVD (13485), and GMP (21CFR820) Quality Assurance teams (sites) across the globe
  • Develop and communicate a Quality vision and strategic objectives that aligns with the operations and business strategy
  • Set network wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality Management System
  • Oversee global Quality Control team performance to meet standard turnaround times, QC test first pass yield (test/retest error), OOS actions, and labor efficiency
  • Manage a complex global matrix organization to ensure the delivery of key CSD projects to customers and regulators (i.e. IronMan, Cascade)
  • Ensure global training is effective and that the plants operate within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective
  • Ensure effective management of quality objectives across multiple sites across the globe in within the Regulated Manufacturing Network of the Life Sciences Solutions Group
  • Set clear roles and responsibilities across the network with pro-active management controls
  • Actively coach technical professionals to achieve maximum performance
  • Ensure effective management of the network / site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, process validation, internal auditing, R&D transfers, and manufacturing area support
  • Provide global quality system leadership to assure internal policies, customer expectations and regulatory requirements are met
  • Leads quality system Management Reviews and serves as Quality Management Representative at various venues
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Quality Assurance Director Resume Examples & Samples

  • Oversees companywide adherence to our procedural documentation (quality management system) and its compliance with ISO 9001
  • Identifies and implements Quality Department goals and objectives in support of company-wide strategic business plans
  • Responsible for ensuring compliance to contracts, the elements of ISO 9001 and EMS policies/procedures throughout GATR
  • Serves as the primary interface with DCMA Quality Assurance Representative to encourage effective communication and good customer relations. Promotes and maintains good relations with the DCMA. Addresses mutual issues and concerns through teamwork with GATR employees and customer representatives
  • Supports the management of budgets and staffing forecasts to facilitate successful execution of the department goals and support of all projects company wide
  • Serves as primary Quality interface and coordinator for engineering and program management issues and manufacturing activities, including production control, procurement, planning, assembly, test and ship
  • Manages the required training, process improvement activities, and the development and implementation of new systems affecting the Quality Department
  • Facilitates the efforts to implement industry-wide/best practice standards
  • Implements a rigorous continuous process improvement program with emphasis on Lean, cycle time reduction, elimination of rework/defects, and root cause analysis
  • Maintains Quality metrics, and a management dashboard of those metrics, and assesses performance against project and enterprise goals
  • Implements and optimizes the use of tools in support of the quality processes and procedures
  • Coordinates with all GATR facilities (and Cubic facilities as appropriate) to converge on common tools, common processes and common data/reports/metrics
  • Represents the Quality organization, as necessary, during Physical Configuration Audits, Material Review Boards, Configuration Control Boards, Corrective Action Boards, Manufacturing reviews and customer meetings
  • Manages the day-to-day operation of all quality functions: inspection, MRB, supplier management, Quality Engineering, corrective/preventive actions, etc
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Senior Director, GLP Quality Assurance Resume Examples & Samples

  • Work with the QA management to define the strategy for quality management in WuXi AppTec Co., Ltd. GLP Laboratories including process reengineering or continuous process improvement and quality training
  • Support the development and implementation of a WuXi AppTec Co., Ltd. GLP-wide quality system and Quality Management System (QMS)
  • Participate in the expansion of GLP principles and international laboratory quality standards (e.g. ISO) to other laboratory areas in WuXi AppTec Co., Ltd. as requested
  • Participate in communication with all levels of laboratory personnel and line management on purpose, direction, and goals of quality management
  • Review and approve QA regulatory documents when required
  • Conduct and report QA activites in support of BU regualtory activities, i.e., study inspections/audits, vendor audits, and facility inspections
  • Assure regulatory authority inspections are fully supported
  • Provide input to GLP QA Suzhou SOPs, and BU Operational SOPs
  • Ensure consistent inspection practices of GLP QA operations within China
  • Assume the responsiblities and role of VP GLP QA when delegated
  • Monitor local projects so that work is on course to meet regulatory or client submission dates
  • Oversee local QA work prioritization and resource management
  • Provide local QA groups with general direction and guidance
  • Degree in Natural Sciences or Medicine or related experience
  • At least 15 years experience in medical or preclinical Research & Development
  • Understanding of Quality systems and global regulatory (GLP) requirements
  • Excellent interpersonal and leadership skills
  • Excellent communication, both written and oral, in English and Mandarin
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Director, Clinical Quality Assurance Resume Examples & Samples

  • Leads the development/enhancement, implementation and maintenance of the CQA Quality Management System and oversees associated activities
  • Responsible for oversight and leadership of CAPA program and quality risk management to enable timely identification and communication of compliance issues/risks, including trend analysis and quality metrics review to foster optimized compliance and continuous process improvement
  • Develops and presents periodic reports describing quality/compliance metrics/trends and identifying areas of potential risk to senior management
  • Provides GCP compliance consultation to clinical teams and other stakeholders on process enhancement/compliance and quality issue management, ensuring consistent quality standards and fostering strong working relationships
  • Leads vendor quality oversight activities and serves on any assigned operational and/or governance committees
  • Oversees administration of SOPs/WPs which facilitate execution of both in-house and outsourced clinical trials/programs compliant with ICH/GCP standards
  • Ensures GCP/SOP/Inspection Readiness training programs are maintained and provided as appropriate to all global staff supporting clinical trials
  • Provides oversight for GCP, SOP, and WP training compliance for staff within CQA Training Administration remit
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Director of Quality Assurance Resume Examples & Samples

  • Serves as the leading technical expert in the area of quality assurance engineering for the company
  • Manages a team of 20+ senior/staff quality engineers worldwide (US, China, Taiwan, Japan, Korea and Europe)
  • Overall responsibility for interfacing with external customers on all product quality issues
  • Actively supports automotive product qualifications and assures compliance with AECQ standard
  • Interfaces with both internal groups (such as Design, Process R&D, Applications and Marketing), as well as external customers for product quality issues
  • Serves as the key technical contact to communicate product quality issues identified internally as well as from customers with OmniVision’s supply chain (foundry fab, packaging and final test) and drive improvement across the supply chain
  • Bachelor’s degree (minimum) in engineering, science or related discipline
  • Minimum 7 years of experience working in semi-conductor quality assurance engineering with knowledge of CMOS Image sensors
  • Experience interfacing with customers on product quality issues and driving to closure
  • Some understanding of wafer fabrication process and familiarity with packaging and final test
  • Knowledge of automotive standards and terminology such as AECQ, PPAP, APQP and FMEA
  • Familiarity with LCOS (liquid crystal on silicon) is very helpful
  • Some direct supervisory experience of technical contributors
  • Excellent written, presentation and interpersonal skills are required
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Global Quality Assurance Director Resume Examples & Samples

  • Primary business partner stakeholders in Singapore, Chicago IL, Redmond WA, Minneapolis MN, Munich GE and Hyderabad IN
  • SBD stakeholders in Charlotte NC, Ft. Lauderdale FL, Singapore, London UK, Dubai UAE, Raleigh SC, Sydney AU, Paris FR, and Redmond WA
  • The role will require travel 20-40% for QA LT meetings, Domain/Functional meetings and stakeholder meetings
  • Demonstrated ability to influence and collaborate with cross-functional teams and realize the business value of a growth mindset
  • Strong executive presence and demonstrated ability to build, extend and maintain senior stakeholder relationships and be their independent trusted advisor
  • Disciplined self-motivation, ability to work independently and within a matrixed team environment, with strong execution and attention to detail
  • Soundly demonstrated data-based decision-making, analysis and problem solving skills
  • Excellent interpersonal, verbal and written communication, analytical and presentation skills
  • Familiarity with creating and managing process & standards
  • Very strong understanding of and skills in the financial – risk-reward – trade-offs in good project management
  • The successful candidate must be willing to adapt to cross-time zone meetings and travel globally for quality reviews, coaching and connecting with management ~20% of the time
  • Must have a degree in business with at least 8 years in quality / risk management / services experience. Quality certification expertise (e.g. ISO, CMMI, Six Sigma) strongly preferred. PMP (PMI) certification required. Risk Management certification preferred (e.g. RIMS-CRMP, PMI-RMP)
  • Trusted Advisor; Building Customer/Partner Relationships
  • Influencing for Impact
  • Contracts, Negotiations and Delivery
  • Judgement
  • Planning, Organizing and Executing
  • Dealing with Ambiguity
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Quality Assurance Director Resume Examples & Samples

  • Capable of performing the functions and be knowledgeable of aviation ground safety and management
  • Shall posses or can qualify for a U.S. states driver license
  • Shall possess an extensive background in the field of aircraft maintenance and quality assurance with a minimum of 15 years of experience with 10 years of the last 15 years in direct aircraft maintenance repair and inspection
  • Of the ten years of experience in aircraft maintenance and quality assurance, six years shall be in a supervisory position that included responsibility for assigning quality assurance program workloads as well as performing quality assurance monitoring functions
  • Must have experience supervising quality assurance personnel supporting scheduled and unscheduled maintenance
  • Experience writing with clarity and technical accuracy
  • Must have experienced interpreting technical publications, blueprints, wiring diagrams, aperture cards, and inspection findings; and have complete knowledge and understanding of aircraft logs and records
  • Shall have sufficient knowledge and experience to effectively assume responsibility for the overall quality of the Contractor maintenance effort in accordance with the CNAFINST 4790.2 Series
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Director, Regional Quality Assurance Resume Examples & Samples

  • In coordination with the VP of Corporate Quality, the other Regional Quality Directors, Quality Assurance and related peers within the Global Quality organization, the Director Regional Quality Assurance will work to lead the successful roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards
  • Provide leadership and resource management support to Corporate Quality and Affiliates located within regional area
  • Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GXP guidelines
  • Ensure Alexion is kept fully informed of new or emerging GMP, GDP and regulatory changes in their region and assess impact of regulatory change on Corporate policies and procedures
  • Lead the review and implementation of Quality Improvement/remediation plans for their regional Affiliates identified through Quality audits
  • Participate as a contributing member of the Regional Leadership Team to assure goals and priorities are supported within the Quality System
  • Provide Quality Expertise and leadership to their designated Affiliate and lead local/regional Quality activities. Assure sites are in a state of inspection readiness and lead support during internal and external inspections/audits. Partner with R&D and PV as required for GVP audits and inspections
  • In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
  • Monitor compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality
  • Act as Quality liaison between the local operational groups and Corporate Quality for GMP/GXP/GDP functions and activities
  • Partner with local, regional and global operational groups to foster a proactive approach to compliance
  • 10-15 years+ of Quality Assurance / Compliance management experience in pharmaceutical/ biotech industry
  • Strong leadership ability
  • Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to GXP, particularly those related to product distribution as required
  • Exceptional communication and interpersonal skills
  • Ability to work globally in a matrix environment
  • Ability to influence senior management, peers and other colleagues without direct reporting lines
  • Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
  • Ability to multi-task and prioritize work
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Senior Director of Quality Assurance Resume Examples & Samples

  • Develop and maintain compliant quality system that adheres to FDA regulatory expectations both internally and with respect to oversight of the company’s suppliers
  • Responsible for ensuring that all investigational and potential commercial drug substances and drug products are manufactured in accordance with Ardelyx’s requirements and as stated in applicable regulatory filings and in compliance with the cGMPs
  • Responsible for timely review and release/disposition of drug substance/drug product/clinical trial supplies to support Ardelyx’s company goals
  • Review and approve analytical/stability protocol, data and reports, maintain stability data base
  • Oversee qualification, performance tracking, and reviews of contract manufacturers and laboratories and manage internal and external audits
  • Approve and issue specifications, and methods for drug substances and products
  • Review and approve IQ/OQ/PQ and validation protocols, tech transfers and reports, as applicable, for all manufacturing, testing, and packaging activities at all CMO’s
  • Serve as the QA representative on project teams and Head the Ardelyx’s Quality Committee
  • Support qualification/validation of GxP related computer based systems; support process validation studies and tech transfer as needed
  • Provide recommendations for corrective and preventative action to the functional area groups/teams
  • Maintain Quality documentation files, databases, and logs
  • Work with CMC, non-clinical, clinical, regulatory, etc as an active cross-functional team member to ensure the appropriate document/data integrity for regulatory submission and PAI preparation
  • Build quality function, with requisite budget and resources to support company’s eventual product commercialization
  • Oversee GCP compliance with respect to clinical site and CRO audits
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Director, PV Quality Assurance Resume Examples & Samples

  • Assists with the development and implementation of the global, internal Quality Assurance (QA) Program for the assigned region, including attracting and developing QA staff resources to cover the QA Program needs in the assigned region
  • Maintains an on-going schedule of QA audits in the region to ensure that required levels of audits of various types and timelines for audits are met
  • Remains current on regulations and guidelines related to the conduct and reporting of clinical trials. Proposes strategies for the implementation of new or revised regulatory requirements for the assigned region, including development of training and/or working with the Training Department to develop training for operational staff on relevant regulatory requirements and revisions to such training
  • Assists with the development and review of QA procedures, audit plans, checklists, and other tools
  • BA/BS degree in a scientific discipline or health care field or equivalent combination education and experience
  • Extensive experience in quality assurance in a clinical research organization or Pharmaceutical/ Biotechnology company
  • Prior experience with managing and supervising multiple staff schedules and deliverables
  • Effective organizational, presentation, documentation, interpersonal, and attention to detail skills
  • Strong and comprehensive knowledge of Good Clinical Practice regulations and guidelines, particularly in the assigned region
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Clinical R&D IT Quality Assurance Director Resume Examples & Samples

  • Lead the strategic development, implementation, application, and continuous improvement of Quintiles TS Delivery Assurance processes and systems meeting both operational and regulatory requirements globally
  • Lead Quality and Validation function for QTS, with direct or cross-functional management responsibility for global resources and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the value of QTS Delivery Assurance related processes and systems
  • Facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on quality and compliance related objectives, plans, and priorities
  • Keep abreast of the evolving regulatory policy and industry best practices related Quality and Compliance
  • Develop business cases for proposed investments and changes in systems, processes, staffing, and organizational development for QTS Delivery Assurance, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making
  • Provide expert advice to leadership and functional area managers on quality, testing and validation, regulatory, compliance, and documentation related issues, including those with department-wide or external impact
  • Collaborate with functional areas to establish and update metrics that are reported to leadership that highlights risks and key opportunities for continuous quality improvement
  • Provide Quality, SDLC, and documentation related input to software product development and project delivery processes to maintain compliance with the relevant regulations and international standards
  • Provide input and resources to author, review and finalize quality-related documentation
  • Identify and suggest functional improvements to the Delivery Assurance related processes and systems
  • Partner with teams responsible for Quality and validation software and all other related tools/technologies to support company needs in this area
  • Support and oversight of corporate CMMI related efforts for QTS including advising project teams on necessary changes to processes, documentation, and associated training
  • Oversees QTS Quality and Compliance management to ensure internal standards and procedures for Computer System Validation remain effective at delivering compliant IT solutions
  • Provides guidance to QTS teams on interpretation and application of procedures applicable to the implementation and operation of IT systems
  • Provides regulatory and software quality knowledge and expertise to support high quality application development and deployment while embracing a risk-based approach
  • Provide leadership and direction to ensure documentation and testing practices meet applicable regulatory requirements, company policies and quality standards, using sound computer system validation and QA testing practices
  • Provides oversight and approvals of risk assessments related to IT systems and platforms
  • Collaborates with corporate Quality and SCO functions for pre-audit and audit planning, support for internal and external audits, and leadership and oversight for potential findings and CAPAs from audits
  • Works with project managers to establish work scheduling plans in support of project schedules. Provides resource estimates for QA and validation efforts related to project and budgetary planning
  • Manages resource allocation to approved projects and ensure project timelines are met
  • Monitors new and emerging regulatory requirements and good practice guidance for GxP computerized system, IT controls and compliance
  • Bachelor degree in Computer Science, or engineering or related field
  • Minimum 12 years of experience in Delivery Assurance or QA leadership and management roles with direct or cross-functional management responsibility for personnel and responsibility for a broad spectrum of Pharma Software Development and/or Solutions and Services Delivery related Quality and Compliance elements
  • Demonstrated success leading cross-functional development, implementation, application, and maintenance of Delivery Assurance processes and systems
  • Strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity
  • Detail-oriented with strong organizational skills and high quality standards
  • Good interpersonal and verbal communication skills, with the ability to effectively communicate with employees, functional area and executive management, customers, and business partners
  • Is considered an expert in computerized system lifecycle management and has experience in the application of industry best practices
  • Well versed with regulatory compliance (GxP, 21CFR Part 11, CMMI, EU Annex 11 etc.)
  • Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP-5, NIST, ICH
  • Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause
  • Experience in participating in regulatory inspections, presenting/defending IT functions in audits or regulatory inspections
  • Bachelor’s Degree in Computer Science or related field; with 12 years IT experience including previous management experience or equivalent combination of education, training and experience
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Director, Sales Quality Assurance Resume Examples & Samples

  • 1 Provides consultative support to Sales and Owner Services in developing appropriate quality assurance standards and measurements that track outputs to standards
  • 2 Reviews Major Projects and understands the impact of key organizational deliverables on the change landscape
  • 3 Implements enhanced quality assurance routines in concert with the lines of business to ensure that materials provided in response compliance reports and rescission feedback are complete, fully responsive and meet quality standards
  • 4 Builds an effective and productive relationship with Owner Services and Sales leaders that drives accountability within the lines of business as well as pushing back and negotiating where appropriate on topics of response timing, content to be delivered, etc
  • 5 Creates continuous service improvement loop to ensure root cause of any issues during the change and that lessons learned are documented and available
  • Ability to prioritize and organize tasks required to manage projects
  • Change management skills
  • Microsoft PowerPoint - Executive level presentations
  • Strong knowledge of the Change Management processes and tools
  • Strong knowledge of Project Planning and Management tools
  • Ability to interface and influence Executive management. Takes and gives coaching (team player) Strong conflict management skills
  • Strong analytical and problem-solving skills with attention to detail
  • Working knowledge of Regulatory Compliance and Operational Risk Management
  • 7+ years directly related business experience
  • 3+ direct work experience Sales Compliance
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Director of Quality Assurance Resume Examples & Samples

  • Lead and manage a QA team of employees in Canada involved in new product development
  • Build, manage, define and implement the QA methodologies, processes, procedures, systems and schedules that will ensure delivery of predictable, high-quality product releases
  • Define and drive the testing strategy and plan from requirements through product release, including regression, functional, exploratory, and other testing
  • Intelligently build automated and manual test suites to drive efficiency and productivity throughout the organization
  • Inspire confidence and add additional leadership strength to the broader management team
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Quality Assurance Director Resume Examples & Samples

  • Establish and maintain systems, policies and procedures to ensure product quality and compliance
  • Lead the Quality Assurance team to ensure that company priorities and timelines are met
  • Lead monthly Quality meeting and ensure that relevant metrics are defined, presented and reported in meeting minutes
  • Work with cross-functional validation teams to ensure that validations fulfill regulatory and laboratory director requirements
  • Maintain all Clinical Laboratory regulatory licenses and ensure renewal of licenses as required
  • Work with regulatory agencies to ensure the laboratory environment exceeds standards and prepares and coordinates laboratory inspections
  • Manages and maintains the document control system
  • Ensure that SOPs, logs, validations, worksheets and other quality records are reviewed and approved
  • Establish software/bioinformatics pipeline documentation
  • Lead sponsor and regulatory audits/inspections
  • Performs and documents internal audits and makes recommendations for corrective actions
  • Ensures proper evaluation and completeness of investigations, root cause analysis as well as corrective and preventive actions (CAPA)
  • Ensure compliance with current applicable regulatory requirements
  • Train personnel on Quality System policy and procedures
  • Track and trend planned and unplanned deviations, out of specification quality control results, complaints, and corrective actions
  • Minimum 5 years Quality Assurance experience in the medical device and/or clinical laboratory environment, understanding of product development, quality control and services
  • Minimum 3 years QA supervisory experience. Experience in establishing CLIA, CAP and/or QSR Quality Systems, experience with ISO 15189 is a plus
  • Experience working in CLIA-certified and CAP-accredited laboratory settings and operations
  • Experience working with software engineering and bioinformatics team to implement processes
  • Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, change management, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management, etc
  • Extensive experience with high-throughput laboratory operations
  • Experience in a start-up environment
  • Dynamic individual with the ability to communicate and engage others
  • Self-Starter
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Senior Director of Quality Assurance Resume Examples & Samples

  • You'll lead the department in the area of QA testing methodologies through to implementation
  • You will provide subject matter expertise in the Quality Assurance discipline in order to define/improve the ICS QA process
  • You'll be responsible for the hands-on, daily management of 8-10 direct report staff workload
  • You will handle the active resource management and allocation of project assignments of the QA staff ensuring their deployment on key projects is on time
  • You will prioritize, handle, and execute multiple tasks, define problems, and resolve issues with limited supervision from senior management
  • You'll provide project management and oversight on project scope and testing strategy. *DICE_TA *LI-ME1
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Director of Quality Assurance Resume Examples & Samples

  • 10+ years of progressive experience in a Supervisor / Management role within a Hospital or other Healthcare related organization
  • 3+ years of Utilization Review experience; 3+ years of experience in a Quality Management position
  • Master's Degree in a related field
  • Certified Professional in Healthcare Quality (CPHQ)
  • Solid assessment, clinical, and documentation skills
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Quality Assurance Director, Middle East Resume Examples & Samples

  • Responsible as the Lead Quality Custodian for the Middle East Region and bring Quality Leadership within the region’s offices by enforcing the AECOM quality system and policies
  • Responsible to ensure consistency between the project management and quality systems implementation within the region’s offices and projects, including any updates presented from EMIA and Global levels
  • Responsible for liaising and guiding the business lines within the Middle East offices for quality related matters
  • Responsible for liaising and guiding the Project QA Representatives within the region on quality related matters
  • Responsible for ensuring that the QA Representatives properly maintain complete and accurate documentation within the region and is passed on to the Centralised QA Admin Team in a timely manner
  • Responsible for coordinating and monitoring the execution of the internal quality audit programme by the QA Representatives on the Country Offices and selected projects, and assist the Lead Auditor EMIA with the external third party certification audits as needed
  • Responsible for ensuring the Monthly Quality Reports (corporate and project KPI data) is collected by the Centralised QA Admin Team from the Middle East QA Representatives and evaluate to identify performance, trends and issues, and areas for improvement which are summarised and presented to the Middle East Management and the QA Director EMIA for review
  • Responsible for ensuring that the required quality awareness is presented to the region’s offices and QA Team
  • 10 to 15 years’ experience within a similar role
  • Minimum 5 years’ experience as a Lead Auditor
  • High level strategic management and organizational skills
  • Excellent working knowledge of industry practices/safety/quality management systems
  • Experienced in statistical reporting including KPIs and trend analysis
  • Excellent communication skills using the English Language
  • Civil Engineering Degree or a related field, incorporating quality qualifications
  • Certified Lead Auditor for ISO 9001 (latest version), with ISO 14001 and OHSAS 18001 (latest version) as a plus
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Quality Assurance Director Resume Examples & Samples

  • Provide the overall leadership in the areas of quality management systems, regulatory compliance, quality control laboratory functions, documentation control, quality audit functions, both internally and with contract manufacturers and packagers. This includes assuring that all product specifications and all regulatory requirements have been satisfied prior to the final release of any product into the distribution channel
  • Responsible for developing/ deploying the Quality strategic plan and assuring the integration/ alignment into commercial quality strategy
  • Interfaces with commercial president in areas of quality decisions, such as escalations, field actions and or other significant quality issues
  • Act as the primary interface with international, federal, state and local regulatory officials in regards to the manufacture and release of any drug product and medical devices by Reckitt Benckiser North America
  • Ensures QMS supporting commercial businesses are in constant state of readiness for planned and ad hoc regulatory audits or inspections
  • Provide leadership to the quality organization that has the final responsibility for the release of any product by Reckitt Benckiser North America. The release criteria includes the review and acceptance of all testing data supporting the release of the product against specification; the review and approval of all documentation generated during the manufacturing and packaging processes; and the overall compliance to cGMP guidelines during the receipt, storage, manufacturing, packaging, and testing of the final product
  • Assure that all complaints involving product quality are thoroughly investigated, examined for trends, reported to senior management, and effectively addressed by corrective and preventive actions as deemed appropriate. This position also provides leadership in any recall situation
  • Assure that annual reports for commercial products are completed in a timely basis
  • Follow Hazardous Waste, General waste and Recycled Waste management and Disposal procedures. Supports Safety, health and Environmental by complying Company policies and procedures regarding safety and employee conduct
  • Bachelor’s degree in a scientific or technical field (i.e.Chemistry, Chemical Engineering,
  • Material Science, etc.)
  • Demonstrated ability to act in a leadership capacity developing and implementing business / quality processes and strategies, leading managerial and professional technical personnel, and coordinating the execution of multiple complex projects in a fast paced environment
  • Must have a strong working knowledge of applicable parts of Title 21 of the CFR and significant leadership / managerial responsibility for quality systems development and maintenance in the pharmaceutical or medical device industry
  • Must have experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem solving teams, etc
  • Ability to deal confidently and effectively with agents of governmental regulatory bodies as well as internal and external customers and suppliers
  • Must exhibit excellent communication and facilitation skills, both oral and written
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Director, Clinical Quality Assurance Resume Examples & Samples

  • Serves as the Clinical Quality Assurance leader in Europe in the implementation and refinement of processes to ensure that Takeda maintains sponsor oversight of the quality of its development activities in compliance with applicable regulatory requirements
  • Collaborate with the Senior Director, Clinical Quality Assurance, Americas and Europe to develop and implement the strategy for sponsor quality oversight of regional development activities
  • Develop regional Quality Management plans for development programs, and tactical audit plans
  • Analyze audit program results, quality issues and investigations in order to identify actionable trends and to promote a state of compliance
  • Identify compliance issues and conduct investigations for regional development activity. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution
  • Manage inspection readiness activities and represent Takeda as a clinical quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda’s good standing with regulatory agencies. Ensure that clinical inspection commitments are fulfilled on time
  • In collaboration with R&D Clinical Supplier Quality, determine acceptability of clinical suppliers for potential use by Takeda
  • Serve as a member of the Clinical Quality Assurance Leadership team, giving input to key strategic decisions
  • Ensure strong alignment with R&D Quality Systems and Compliance and R&D Quality Services and Improvement
  • B.Sc. in Science, Nursing, or related scientific field. M.Sc. preferred
  • Extensive applicable pharmaceutical and/or biotech development experience with a solid understanding of GCP-related Quality Assurance
  • Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states
  • Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines
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Director, Pharmacovigilance Quality Assurance Resume Examples & Samples

  • Serve as the Pharmacovigilance Quality Assurance leader in Europe in the implementation and refinement of processes to ensure that Takeda maintains oversight of the quality of its pharmacovigilance activities in compliance with applicable regulatory requirements
  • In collaboration with R&D Pharmacovigilance Quality Assurance develop tactical and strategic audit plans
  • Identify compliance issues and conduct investigations for regional pharmacovigilance activity. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution
  • Manage inspection readiness activities and represent Takeda as a Pharmacovigilance quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda’s good standing with regulatory agencies. Ensure that Pharmacovigilance inspection commitments are fulfilled on time
  • In collaboration with R&D Supplier Quality, determine acceptability of Pharmacovigilance suppliers for potential use by Takeda
  • As assigned, conduct due diligence assessments of prospective in-licensing opportunities and acquisitions to identify key quality assurance and compliance risks. Conduct document reviews and on-site assessments as required
  • Extensive applicable pharmaceutical and/or biotech pharmacovigilance experience with a solid understanding of GVP-related Quality Assurance
  • Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity
  • Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions
  • ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred
  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel will be required
  • Requires approximately 50 % travel
  • LI - MD1 - EUR
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Claims Quality Assurance Director Resume Examples & Samples

  • Effectively plan each review including review date range and communicating review scope to appropriate parties
  • Keep the appropriates parties advised of the status of the current review results while recognizing and communicating trends, training needs, compliance requirements or process reviews required
  • Perform effective wrap-up meetings with the appropriate parties specifically identifying any follow up activity such as training, communication updates, compliance, and process review requirements
  • Assist with coordinating with IT, Compliance, and Internal Audit with necessary updates, changes or communication needs
  • Complete follow-up reviews as necessary to determine whether deficiencies are corrected
  • Manage various Claims Software Systems (adding and removing users/clients, maintaining accurate authority levels, etc.)
  • Monitor shared drive reporting for Claims Exception Reporting, Direct Check Reporting and Claims Monthly Management reporting to ensure processes are completed timely and accurately in order to ensure compliance with internal audit controls
  • Oversee all compliance processes for state as well as federally mandated reporting systems
  • Assist with other Business Analyst Projects as needed including Vendor Management, Data Analysis, Presentations, and Training Developments
  • Manage Claims QA Unit and provide direction as required
  • Review and evaluate review process to meet company needs
  • Mentor and coach Claims QA associates to develop skills, increase job knowledge and achieve stated performance objectives
  • Set goals and objectives for staff, providing quarterly and annual appraisals
  • Collaborate with Claims Operations to identify and prioritize key risks
  • Identify primary controls, key metrics and best practices
  • Develop and implement advanced systematic monitoring and assessment of process compliance that emphasizes root cause analysis and continuous improvement of claim outcomes
  • Independently analyze claims data and identify patterns and relationships within data sets
  • Conduct testing, document findings and develop written recommendations
  • Assist with the design and implementation of changes to policies and processes
  • Assist in supporting and evaluating existing or new systems/programs
  • Assist with coordinating with leaders in all relevant departments in maintaining and expanding Quality Assurance’s role as needed
  • Establishes and executes controls to ensure that the quality of the auditors work meets or exceeds standards
  • Extensive experience with non-standard automobile insurance operations is a plus
  • Team player with a strong collaborative orientation; ability to build strong relationships across an organization
  • Excellent interpersonal skills including strong verbal and written communication skills and ease in interacting with associates
  • Strong analytical and technical skills
  • Creative problem solving and critical thinking/decision making skills
  • Organized, detail oriented and a self-starter
  • A minimum of five years of audit, process improvement, project management, analytics and/or quality assurance. Claims experience is preferred
43

Director, Post-marketing Quality Assurance Resume Examples & Samples

  • Ensure quality systems are compliant with corporate and site procedures as well as industry standards
  • Drive continuous improvement initiatives
  • Facilitate, participate, review, lead and/or approve investigations, root cause analysis, change controls, etc
  • Effective coordination of functions across the site and with externals to drive timely review, approval, and closure of investigations, change controls, corrections, and effectiveness checks
  • Promote and induce quality mindset culture in SSF
  • Manage and supervise US QA function
  • Maintain close working relations with all relevant business units in SSF, in particular Market Access, Drug Safety, Medical, Regulatory, Legal, Marketing, with the aim to strengthen Quality and provide consultation
  • Assist business units in establishing robust quality procedures and training activities
  • Write and maintain SOPs pertaining to SSF QA function in alignment with PMQA processes
  • Evaluate and assess deviations
  • Perform QA relevant training to staff on audit, root cause analysis, CAPA handling and Good Documentation Practices
  • Manage and oversee all local GxP audits and assessments, including but not limited to PV, REMS, GMP audits at Specialty Pharmacies, inpatient pharmacies, and data/IT audits (AIM). Note: audits and assessments related to GCP and hub services remain with PMQA/CSV QA respectively
  • Establish effective lines of communication with relevant business functions (Market Access, Application and Information Management, Drug Safety,…); and ensure timely notification of GxP activity outsourcing plans by business functions
  • Apply risk assessment methodology to define audit need and periodicity of audits
  • Assess and select contractors performing audits on behalf of Actelion SSF and act as their contract giver
  • Ensure proper root cause analysis / CAPA follow-up, involving business function
  • Act as host to GQM audits (PMQA, CSV QA) and coordinate coEstablish and maintain inspection readiness processes including set up of team managing inspection requests ("war room")
  • Host FDA inspections at Actelion SSF, in collaboration with DS
  • Oversee all interactions during inspections including provision of documentation, briefing/ debriefing with irresponding CAPAs with CAPA owners
  • Master’s Degree in Science (Chemistry, Microbiology or Biology preferred) ; Advanced degree preferred
  • A minimum of seven to ten years related experience and/or training and/or equivalent combination of education and experience in Quality Assurance. Prior Quality Assurance experience is required
  • Strong knowledge and experience in in quality assurance (QA), pharmacovigilance (PV), REMS
  • Solid understanding of US and international PV regulations and guidelines (CFR, ICH...) as well as their practical implications
  • Experience with hosting FDA inspections, familiar with FDA working processes
  • Strong leadership, communication skills
  • Persuading skills
  • Excellent organizational and leadership skills, and ability to work under pressure and tight timelines
  • Thorough knowledge of domestic and international regulatory reporting requirements
44

Director Product Management & Quality Assurance Resume Examples & Samples

  • Manage daily relationship with technology vendors involved in releases for brand and corporate websites, identifying recurring and ad-hoc deliverables, driving quality and timeliness of deployments with minimum defects
  • Create repository of business requirements to document the functionality behind all sections of the transactional sites, and review/approve requirements for new functionality and site defects
  • Drive strategy and manage maintenance of digital platforms and integration processes for continuous reliability and revenue growth
  • Define testing strategy, success criteria, structure test plans and testing materials, engaging with stakeholders across the company to assign testing tasks and drive successful completion when software releases are deployed
  • Plan required steps on the Digital Products, IT and Vendors for a regular and effective release management process, working with appropriate teams to update functional requirements and perform user acceptance testing
  • Define cadence for triaging and prioritization of defects, leading internal and external teams to assess effort, revenue impact and technical and business dependencies
  • Hire, develop and train team to achieve high performance practices
  • BA/BS in Computer Science or Business required (MBA is a plus)
  • 6+ years of experience in internet platforms, ideally in transactional websites with solid knowledge of shopping/retail functionality, cloud technology and API connectivity
  • 3+ years of experience leading functional or technical teams
  • 3+ years of experience with software testing and Quality Assurance
  • 2+ years working in Agile software development working practices
  • 3+ years of experience with third party integrations and management of technology vendors
  • Solid understanding of web and mobile technologies and the innate curiosity and desire to learn more
  • Passion for travel; experience in hospitality or retail is a plus
45

Director, GMP Quality Assurance Resume Examples & Samples

  • Develop and direct consistent QA programs within the NA Biologics operation, ensuring compliance with cGMP and other pertinent federal and state regulations, international standards, corporate policies, and customer requirements
  • Working with the Senior Director of Global GMP QA to coordinate site compliance and global quality programs to help assure consistency
  • Manage the cGMP NA Biologics QA functions in support of multiple domestic sites/locations
  • Provide assistance on global GMP programs/goals to ensure proper harmonization across the sites
  • Participate in the CRL Global QA meeting, Corporate QA/RA policy development, joint Operational/QA meetings and strategic planning sessions
  • Assist in the development and implementation of audit programs, including both internal and external auditing, in support of the NA Biologics business segment
  • Provide regulatory guidance to internal departments for the development of test methodology, new facility construction, new manufacturing process, etc
  • Prepare regular compliance reports that advise management of the state of compliance within the NA Biologics facilities
  • Direct and mentor the Quality Assurance staff supporting NA Biologics operations
  • Identify and develop high-potential employees, through development plans, in support of the company’s succession planning process
  • Ensure that management training and development needs are identified and programs initiated. Direct the development of departmental orientation and other training programs
  • Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports
  • Develop short- and long-range operating objectives, organizational structure, and staffing requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel
  • Education: Bachelor’s degree (B.A./B.S.) or equivalent in scientific or related discipline/field
46

Senior Director of Quality Assurance Resume Examples & Samples

  • Takes ultimate responsibility for the direction and effective management of all departments within the quality assurance function, ensuring that each department is resourced, structured and managed to support the goals of the organization. Departments include, but not limited to
  • Calibration * CAPA
  • Compliance * Document & Data Control
  • Internal / External Quality Audit * Quality Control, Product Release
  • Management Review * Quality Inspections
  • Quality Engineering * Real Time Aging
  • Field Assurance * Risk Management
  • Supplier Quality
  • Validation (Product & Process)
  • Assigned Quality System Management Representative for Merit Medical Systems Inc.; primary regulatory agency and customer contact on all quality related queries globally e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements
  • Instrumental in setting strategy to enhance and maintain Merit Medical Systems Inc. Global Quality Assurance Programs, to meet the required regulations applicable to the processes managed, products produced, and global markets served e.g. US, South America, Canada, EMEA, APAC, CSR (Customer Specific Requirements)
  • Key member of Senior Leadership Team that manages, develops and drives Merit Medical Systems Inc. to deliver the goals of the business i.e. Best In Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development
  • Promote, support the "Merit Business Excellence System" Program; lead by example; partner with functional leaders to ensure that this program, the organizations objectives and values are at the forefront of decision making and action
  • Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction
  • Develops capital plans and budgets for the Quality Assurance Department
  • Provides Merit Medical Systems Inc. with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer by
  • Developing and directing annual 'Quality Assurance" team goals to deliver the key company objectives and continuous growth of personnel
  • Reviewing performance of Quality Assurance staff in achieving compliance and system improvement objectives
  • Preparing or reviewing written procedures and documentation for testing and manufacturing processes
  • Tracking information about customer complaints to provide design, development and operations teams with product quality information
  • Providing recommendations and decisions regarding the disposition of non-conforming products; determines when Regulatory/Clinical approval is required; stops production lines if problems with quality arise and initiates preventive and corrective actions to ensure non-recurrence
  • Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations
  • Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies
  • Partner with Research and Development (Product & Technology) function ensuring
  • Customer requirements are met
  • Safe and effective product design
  • Compliance with design control requirement
  • Design for manufacture
  • Quality at source
  • Smooth transition of new products and Technologies to operations groups
  • Participate, support and provide independent review of all verification and validation activities
  • Functional manager for a team of quality assurance personnel
  • Resource functional areas, projects with the required resources
  • Select, coordinate assigned work, mentor, manage performance for all team members ensuring appropriate corrective action for sub-optimal performance, and recognition of strong performance creating avenues for advancement
  • Manage training and career developmental needs of team to the benefit of the individuals and the organization, ensuring that talent is positioned and utilized for maximum effectiveness
  • May fill in for Vice President, Global Quality or similar position, as directed
  • Lifting -- Not to exceed 50 lbs. -- local practice may apply
  • Writing
  • Sitting
  • Standing
  • Bending
  • Vision
  • Color perception
  • Depth perception
  • Reading
  • Field of vision/peripheral
  • Solid communication skills in English (Must) , Portuguese or Spanish is a plus
  • Education and/or experience equivalent to a Bachelor's Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher)
  • At least ten years of work related experience, of which a minimum of four years' experience in a related management role
  • Proven track record in leading organizations through external inspections / audits (e.g. FDA, Notified Bodies, Competent Authorities, and Customers)
  • Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), ANVISA and JPAL/JGMP
  • General knowledge of the medical device industry and the applications of Merit's products in the medical field
  • Post graduate diploma/Master's degree in Quality Management
  • Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools
  • Strongly prefer medical device manufacturing management experience
  • Strongly prefer proven track record leadership experience in the development of a large, international team, in multiple regions
  • Strong leadership ability and the ability to influence at all levels within the organization
  • Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others
  • Ability to provide functional, cross functional and organizational leadership as required by the demands of the role
  • Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively. Attention to detail without losing site of the big picture
  • Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process
47

Clinical Research Quality Assurance Director Resume Examples & Samples

  • 7-10 years of clinical research experience
  • 4-7 years of management leadership
  • Excellent problem-solving abilities
  • Strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation
  • Superior time management, administrative and computer skills
  • Experience related to Human Subjects Protection (including 21 CFR and 45 CFR 46 of the US Code of Federal Regulations), GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems, and HIPAA
48

Director of Quality Assurance Resume Examples & Samples

  • Advanced working knowledge of QA processes and methodologies; expertise in test planning, test case management, code coverage and defect analysis
  • Experienced in project management and Agile product development life cycles
  • Proven experience working for an established software vendor
  • Collaborative but decisive personal style; highly effective communicator and problem solver
  • Experience with complex business processes
  • 10+ years of quality assurance experience including test planning, implementation and execution, on an enterprise Windows desktop application
49

Director of Quality Assurance Resume Examples & Samples

  • Establish Testing Centre of Excellence
  • Direct the detailed analysis of quality assurance processes within the company, including gathering data, investigating cause-effect relationships, and measuring process performance
  • Engage cross-functional project teams to develop, deploy and measure several concurrent quality process improvement projects and initiatives that will contribute to a comprehensive integrated quality assurance program
  • Develop business cases and obtain executive-level support and approval for implementation
  • Identify and apply industry best practices and benchmarks to develop "best-in-class" QA process models and target performance metrics
  • Implement, track, and continuously improve metrics and reports to support both business process improvements and operations across the company
  • Overall accountability for test processes, test planning and resource management including
  • Functional testing for integration, regression
  • Testing for all changes to production
  • Ongoing improvements to processes, timelines to obtain efficiencies
  • Media Testing
  • Manage external vendors who are engaged to perform testing on Rogers’ behalf
  • Manage Vendor SLAs and KPIs,
  • Challenge vendors on test execution strategy and to provide proof of Knowledge transfer amongst team members
  • Deliver ways to Improve test execution through automation
  • Proactive and comprehensive reporting
  • Lead not just manage the team
  • Post-secondary education in IT, Engineering and/or related process improvement experience is desired
  • 10+ years of progressive experience within IT and QA, including Performance Testing
  • Proven track record for defining and implementing testing efficiencies
  • Experience in creating, improving, or managing an end to end Quality Management Program
  • Experience working with a matrixed team of directors and managers
  • Experience in managing and working with testing vendors with on and offshore teams
  • At ease with influencing the different levels of the organization, from managers to vice-presidents, within own function and across functions/LOBs
  • High level of comfort working with and interpreting data
  • Strong interpersonal, communication (written and oral) and presentation skills
  • Energetic self-starter who thrives in a fast-paced environment
50

Director, Global Brand Quality Assurance Resume Examples & Samples

  • BS/MS
  • Demonstrated success in handling multiple cross-functional projects, new product development process, and project management. Demonstrated communication, leadership and human relations skills - able to work well with all elements within and outside of the organization
  • Computer literate with good working knowledge of Microsoft products. (SAP knowledge an added advantage). Strong interpersonal, communications (oral, written, influence and persuasiveness), technical report/writing and presentation skills
  • Ability to travel for 3-4 day periods on short notice
51

Quality Assurance Director Resume Examples & Samples

  • ISO 9001 Audit Systems with internal audit controls and procedures
  • Supplier Certification and Quality Control
  • Records Retention
  • MRB management of excursionary material
  • Sub-contractor audits
  • Minimum of 10 years experience within the semiconductor industry, preferably within a Quality Assurance organization
  • Proven track record of leading teams and projects to successful completion
  • Understanding of ISO9001 control systems and standards
  • History of interacting with suppliers and sub-contractors in a production environment for the purpose quality control
  • Legal ability to travel internationally
52

Quality Assurance Director Resume Examples & Samples

  • Quality standards ISO13485 & MDD etc
  • FDA Regulations & Guidelines, 21CFR820, cGMP/QSR,
  • Excellent knowledge of management systems
  • Excellent knowledge of Quality Assurance and Quality Control processes, Continuous improvement processes, Quality systems, Supplier Quality Assurance practices
  • Change management/processes
  • Managing Team building skills
  • Knowledge of systems: E.g. Microsoft Office, Oracle, & Windchill Document Management Systems
  • Minimum of 15 years experience in QA/QC, preferably in Medical Device Manufacturing. Will have a minimum of 15 years progressive experience with quality processes and systems in a regulated environment (life science) within an international fast growing/changing environment. Experience must include influencing and directing the work of others both functionally and cross-functionally
53

Director of Quality Assurance & Delivery Owner Resume Examples & Samples

  • Overall accountability for strategic alignment of quality and the business
  • Overall accountability for high quality product value deliverables to support line of business strategy
  • Foster relationship between the quality delivery organization and the line of business
  • Accountable for alignment of technical deliverables to policies, standards and best practice guidelines
  • Change agent for promotion to compliance to quality policies, standards and best practice guidelines
  • In close collaboration with the LOB technology team and the QMS COE QA and the strategic partners, ensures the testing technology stack available for each test team is the most effective and efficient for the architecture and design deployed with that LOB’s products, projects, work packages and M&PS efforts
  • Responsible for establishing and clearly communicating the overall test strategy to the QMS and Technology Leadership Team and aligned with key business initiatives that could consist of cloud computing, technology transformations, strategic architecture direction, and shift-left methodologies
  • In coordination with the QA COE the QDO is responsible for establishing the strategy that may consist of, but not limited to, data management and refresh schedule, production staging environments, alpha and production checkout nodes, test system integration with up-line and downline code and system configurations including customer test systems, continuous integration and continuous deployment support, end-2-end testing and monitoring and cloud implementations, cross LOB integration efforts, and cloud based tools
  • Directs the implementation of continuous quality improvements across the team to improve reliability of test systems, improved speed in remediation of issues, closer alignment with product delivery requirements, and proactive measures to improve overall product quality that will result in reduced impact to project schedules and cost related to those delays
54

Quality Assurance Director, Devices Resume Examples & Samples

  • Ensures teams work closely with design, development, quality, regulatory, and supplier/contractor teams to establish and document the master verification and validation plans in conformance with the system design specification and sound testing principles
  • Oversees or assists in planning, coordinating and execution of design verification and validation testing to directly support the master verification and validation plans
  • Ensures teams work closely with the engineering team to establish and drive the design FMEA, FMECA and other risk related activities (ISO14971)
  • Ensures inspection readiness and documentation robustness for programs/products in scope and for Device Quality processes
  • 10+ years of business experience, leading technical organizations in multiple parallel and virtual environments
55

Tax Quality Assurance Director Resume Examples & Samples

  • BA or BS in Accounting, Finance or Business preferred
  • MST preferred
  • CPA certification required
  • 8+ years of tax compliance experience within a public accounting firm
  • Comprehensive tax consulting experience and demonstrated expertise in taxation and knowledge of federal and state tax laws and regulation
  • An ability to effectively present information and appropriately respond to questions from clients and team members
  • A track record of successful new business development experience a plus
  • Excellent analytical, supervisory, organizational, and written and verbal communication skills necessary
  • Experience and continued interest in developing and mentoring junior team members
  • Proficiency in MS Word, Outlook and Excel required
  • Experience with ProSystem FX Engagement preferred
  • Ability to travel as required by business
56

Director, Service Desk & Quality Assurance Resume Examples & Samples

  • Identifies and helps to create training curriculum for new and current users of basic processes of the ticketing systems
  • Drives initiatives to improve and align organization's quality of services, operating model and mindset
  • Establish, measure and exceed service standards and key performance metrics
  • Manages escalations, ITSM initiatives and projects
  • Owns and manages the partnerships with key business stakeholders from divisions and corporate on business operations
  • Able to lead cross-functionally and inspire technical people to 'wow' their customers
  • Acts as liaison between business and vendor to drive towards meeting business requirements
  • Is familiar with Net Present Score for customer satisfaction
  • Determines and delivers metrics not only within the SupportNow organization but across the entire IITS organization
  • Drives automation efforts both from within Comcast and with the vendor
  • Owns and manages contract details and understands if and what might need to be updated
  • Provides weekly updates to leadership and recommends courses of action to resolve any issues or concerns
  • Owns process improvements initiatives and reports on metrics
  • Owns the Customer Experience and drives continuous improvement efforts
  • Performs other duties and responsibilities as assigned
57

Corporate Quality Assurance Director Resume Examples & Samples

  • Provides strategic leadership for corporate quality improvement initiatives
  • Acts as point person for quality and regulatory interactions with sponsors and regulatory agencies
  • Member of Bioclinica’s Corporate Regulatory and Quality Governance Committee
  • Champions process and tool improvements to facilitate comprehensive data and metrics collection projects within Quality Assurance and Regulatory Compliance
  • Leads and directs corporate compliance activities and teams
  • Provides leadership and champions Bioclinica’s Quality Assurance and Regulatory Compliance standards
  • Provides leaderships in ongoing process improvement, process standardization and integration efforts that evolve Bioclinica’s Quality Management System (QMS)
  • Provides QA and Regulatory consultation on systems development, policies and procedures as well as resource planning and staff development
  • Contribute to industry committee activities (e.g. ACRO, AVOCA, TransCelerate etc.)
  • Oversees and directs compliance reviews and internal auditing programs
  • Implements continuous improvement activities to ensure ongoing compliance with the changing regulatory environment
  • Mentors and provides guidance to departments on implementing and maintaining compliant processes and software validation best practices
  • Actively leads and/or participates in management committees and special projects to ensure quality and compliance are built into the company’s activities
  • Champions Bioclinica’s Quality Manual and associated documentation
  • Collaborates with stakeholders in the development of operational training materials and development programs
  • Supports the implementation and improvement of the corporate performance management program
  • Supports the design, development and implementation of effective Quality Management Systems for Bioclinica’s Corporate-Wide
  • Excellent documentation and organizational skills
  • Excellent analytical skills and the ability to work independently
  • Leadership skills and personal qualities to be successful within a matrix organization
  • 12+ years of experience in regulated environments
  • Sound knowledge of clinical research environments
  • Sound knowledge of GxP regulations and guidelines
  • 5+ years management experience in quality assurance and quality systems
  • 5+ years of experience in computer validation processes in regulated environment including 21 CFR Part 11, Annex 11, Japan ER / ES
58

Quality Assurance Director Resume Examples & Samples

  • Manage delivery for QE & A from Client location and serve as the first point of escalation
  • Accountable for overall delivery across multiple projects in the engagement
  • Anchor and drive the steering committee meetings about the delivery status for all projects
  • Regular connect with Clients at VP, CTO and CIO Levels for the delivery and identifying new opportunities (organic / adjacent)
  • Liaise with verticals and other horizontals to bring in synergies and ensure successful delivery
  • Tracking and supporting the activities of project teams to ensure quality and timeliness of program execution
  • Responsible for reporting SLAs, metrics and other critical hygiene factors that impact the Account
  • Ensure engagement objectives are in continuous alignment with the evolving business direction
  • Get first-hand customer information and uses it for improvements in services provided by Cognizant
  • Should be aware of how strategies and tactics work in the client’s environment with knowledge of Cognizant’s competitors as well as broad drivers in client’s business
  • Expected to have high level technical & functional knowledge to explain business problems to Cognizant internal teams and cascade information in most lucid form
  • Assist account managers/client partner in related business development activities to grow mindshare and market share in the account
  • Review solution and estimate for new opportunities
  • Should be able to tactically handle internal escalations among project teams
  • Reporting to our internal senior management or Leadership teams on the overall engagement (across different dimensions like delivery, bid management, staffing, financials etc.)
  • Customer facing experience with background in Health Care
  • Extensive hands-on experience in handling large organization wide transformational programs
  • Should have excellent presentation and written communications skills
  • Strong analytical and negotiation skills
  • Works independently to manage the whole program and respective stakeholders/ and projects
  • Has ownership for key projects’ timelines, deliverables, budget and metrics
  • Project/strategic planning and business background with understanding of assigned areas of responsibility
  • Ability to multitask and react in a fast-paced organization
59

Assoc Director External Quality Assurance Resume Examples & Samples

  • Bachelor degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, or Engineering
  • Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
  • Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management
  • Must have the ability to influence management of complex operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies
  • Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity
  • Must have exemplary people/team collaboration experience, including speaking candidly, and motivating teams
60

Quality Assurance Director Resume Examples & Samples

  • Experience directing Quality Assurance organizations through DevOps and Continuous Delivery transformations
  • Strong knowledge of financial industry and Custody, Clearance and Settlement businesses, processes, disciplines and standards
  • Excellent written, listening, presentation and interpersonal skills
  • Ability to work independently, motivate, prioritize and execute tasks in a high-pressure environment
  • Willingness to work in a fast-paced and dynamic environment where daily, weekly software updates coincide with major project releases
  • A strong understanding of Application Development Life Cycle and various software development lifecycles including DevOps, Agile and Iterative
  • Working knowledge of Java; Database/SQL; MS Visual Studio.NET; Perl; Python; Data Quality; Container Technology
61

Quality Assurance Director Resume Examples & Samples

  • Academic degree
  • Several years of experience within the area of Quality Assurance Management
  • Strong track record from the food ingredient industry, food industry or pharmaceutical industry
  • Strong managerial experience
  • Experience from driving change, promoting process improvement, developing standards and managing processes
62

Director of Financial Quality Assurance Resume Examples & Samples

  • Expert in finance, healthcare revenue recognition, accounting, risk assessment, operational and financial controls, including Sarbanes-Oxley, and cost control principles including Generally Accepted Accounting Principles
  • Demonstrated experience in audit planning and execution
  • Knowledge of change management
  • Knowledge of automated financial and accounting reporting systems
  • Knowledge financial regulations and standards
  • Ability to analyze financial data, reports, statements, and projections
  • Ability to motivate teams to produce quality materials within tight timeframes and simultaneously manage several projects
  • Expert at facilitating group meetings
  • Five years of manager or director-level supervisory experience in finance, audit, or accounting required
63

Program Effectiveness & Quality Assurance Technical Director Resume Examples & Samples

  • Guide and support the two NOs QA leads in strategy review, monitoring and tracking
  • Lead the adaptation of the two NO programs to SAR sector focus and the new global strategy by keeping track of global and regional focus guidance
  • Ensure alignment of strategy to programs through the LEAP-3 adoption process, recommending necessary adaptation, rectification and changes and proper integration of newly joining programs within the greater strategy focus of the two NOs
  • Ensure the two QA leads are technically supported to produce high quality CWBRs on their strategies
  • Strong monitoring framework, systems, capacity with clear roles and responsibilities for data capturing, aggregation, reporting and utilisation including facilitation of reflection processes internally and with external stakeholders including communities and partners
  • Ensure rigorous baselines and evaluations are conducted for Technical Programmes (TPs) and grants
  • Ensure that consultancies are properly managed in all design, baseline and evaluations
  • Promote innovative methods for data collection, reporting and utilisation to create efficiency and improve data quality
  • Develop and execute evidence building plans and enhance the NOs evidence base in quality, diversity and breadth of coverage
  • Ensure Horizon-3 utilisation to maximum benefit of building evidence, management of knowledge and integration of sponsorship and programming
  • Enhance Design Monitoring Evaluation (DME) capacity in capturing change among vulnerable children
  • Identify and collaborate with research institutions and universities for enhancing capacity and quality of evidence in the National Offices (NOs)
  • Develop networks with peer institutions to reduce duplication of data gathering, share WV’s works and evidence and profile the organisation as a leader in the area of evidence
  • Promote NO QA staff participation in relevant CoP to improve engagement and learning within WVI
  • Ensure key organisational identity areas, Child focus, Christian identity and community baseness are effectively integrated in DME practices through the TD philosophy and the DPA approaches
  • Undertake or update ICD and NO capacity building strategy
  • Work and influence to resource the strategy
  • Ensure the strategy is implemented and clear progress milestones are achieved towards making the NO teams equipped to deliver quality evidence
  • Assess NOs capacity, staffing levels for portfolio, skills mixes of the teams and advise leadership on a path to build strong teams
  • Develop staff motivation - Development and retention concept and engage with the SLT for resourcing and support
  • Engage the Senior Leadership Teams (SLTs) with M&E products and the QA teams to encourage progresses made and provide feedback for improvements as well as utilise M&E to inform key decision making
  • Engage the SLTs for adequate resourcing of QA at all years including capacity building
  • Support the two NO QA leads in strong PST engagement and influence the outcomes of PST engagements
  • Master’s degree preferably in a social science field
  • 5 years minimum experience in M&E systems design including applications of technology in M&E processes and knowledge management processes and social research
  • At least 5 years’ experience in relief and development work, out of which at least two years must be in grassroots relief and development work in Africa
  • Commitment to and understanding of integrated ministry among the world’s poorest of the poor and well-being of children
  • Commitment to WVI.’s Mission and Core Values
  • Quantitative and qualitative data analysis with a known software such as SPSS
  • Working with mobile devices and online survey management tools
  • Skills in data analysis using computer programs and experience in design and facilitation of training programmes
  • Excellent presentation and communication skills with knowledge of various technical sectors of development such as food security, primary health care, micro enterprises development, etc
  • Commitment to life-long learning and must be self-motivated to achieve quality results and service
  • Motivated to work effectively in a collaborative team environment and demonstrate competencies in design and implementation of M&E plans at the project and programme levels including the accompanying MIS
  • World Vision Quality Assurance experience is preferred
64

Senior Director, Research Quality Assurance Resume Examples & Samples

  • Directs the strategic direction for the RQA function including GCP,
  • BA/BS required in a science-related discipline
  • The incumbent will have at least 10 years of experience in GCP, GLP and GVP roles in FDA-regulated biotechnology, pharmaceutical or medical device companies. At least 5 years of leadership of a team responsible for GCP/GLP/GVP compliance
  • Experience managing cross-culturally and/or globally is preferred
  • Experience working with CROs under a strategic partnership relationship is preferred
  • Previous experience in conducting GCP, GLP and/or GVP audits is required
  • Comprehensive knowledge of international regulatory requirements and guidelines governing GCP,GLP and GVP
  • Must be a hands-on technical professional when required
  • Demonstrated ability to lead and manage Regulatory Inspections
  • Strong oral as well as written communication skills
  • Ability to travel approximately 20% on average, including trips
65

Regional Director of Quality Assurance Resume Examples & Samples

  • Creates and maintains a strong partnership with senior sales executives, site vice presidents (VPs) and QA team members to meet and/or exceed sales retention and compliance goals
  • Executes and monitors all QA standard operating practices (SOPs)
  • Leads QA teams within business unit to meet and/or exceed all sales targets, retention and goals
  • Hires, trains and evaluates QA managers and team members to successfully perform all assigned tasks
  • Visits sites to monitor and evaluate performance
  • Reviews and analyzes regional and site rescission reports
  • Collaborates with Sales and QA teams to maintain and/or enhance site retention targets
  • Partners with Sales to develop action plans to improve sales performance when below target retention rates
  • Recommends Sales and QA recognition acknowledgements
  • Assists Sales and QA team members to resolve customer complaints with satisfactory results
  • Conducts performance reviews for effective program results
  • Observes closings to assess policy and standards adherence
  • Creates action plans as needed to improve performance
  • Ensures Sales and QA actions are compliant with company and department standards
  • Reports Sales process integrity violations to senior management immediately and provides solutions
  • Provides progress reports to management in a timely manner
  • A minimum two (2) years of experience in the vacation ownership and/or quality assurance field required
  • A minimum two (2) years of supervisory experience in the vacation ownership field required
  • Ability to drive results
  • Ability to motivate team members
  • Ability to train and coach effectively
  • Understands how to develop and implement business strategies
  • Proficient in time management; the ability to organize and manage multiple priorities
66

Director of Quality Assurance Data Security Products Resume Examples & Samples

  • Leadership: Must be able to lead, motivate and mentor a team of about thirty-five (and growing) quality assurance & test automation engineers. Must collaborate and interact well in a cross-functional team setting as well as work closely with peer product teams
  • “Hands on” – Must be willing to roll up the sleeves and gain a deep understanding of how the products work and be able to leverage that knowledge to give guidance to the team
  • Communication skills: Must have excellent written, verbal and presentation skills. Must be able to articulate and present ideas concisely and clearly
  • Ability to push back or hold ground whenever quality of the product should trump the schedule
  • Culture of startup balanced with the needs of a large enterprise SW: Must be able to innovate in QA methodologies for white box/black box testing, driving efficiency through test automation and test driven development
  • Engage & interact with customers and OEMs on discussions related to quality and security as it relates to Data Security products
  • Prior experience as a director or senior director of Quality Assurance at a well recognized enterprise security software/systems company and bringing well recognized products to market
  • Providing quality assurance for data and systems oriented products such as file systems/clustered file systems, volume managers designed to support legacy databases such as Oracle, DB2 etc. as well as the newer generation NoSQL databases such as MongoDB, Cassandra etc
  • Domain expertise in test case management, automation and testing for very large & complex ecosystems
  • Knowledge of test automation frameworks such as Selenium and ROBOT
  • Strong knowledge of NAS and protocols such as NFS and CIFS
  • Strong experience working at system level areas such as networking, security, databases, clustering and performance
  • Experience with testing products that use secure communication protocols such as OpenSSL, TLS, JCA/JCE, PKCS, KMIP etc. to provide data security
  • Track record of leading and managing high performance quality assurance teams in a geographically distributed setting
  • Strong network and reputation within the enterprise software and systems community
  • Managing geographically distributed teams
  • BS in Computer Science (MS Preferred)
67

Director of Quality Assurance Resume Examples & Samples

  • FDA regulated environment: 5 years
  • CGMP: 5 years
  • ISO 13485: 5 years
  • Quality Engineer: 5 years
  • CAPA systems management: 5 years
68

Senior Director of Quality Assurance Resume Examples & Samples

  • Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process
  • CAPA
  • Compliance
  • Document & Data Control
  • Internal / External Quality Audit
  • Quality Control, Product Release
  • Management Review
  • Quality Inspections
  • Real Time Aging
  • Field Assurance
  • Assigned Quality System Management Representative for client: primary regulatory agency and customer contact on all quality related queries globally e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements
  • Instrumental in setting strategy to enhance and maintain Global Quality Assurance Programs, to meet the required regulations applicable to the processes managed, products produced, and global markets served e.g. US, South America, Canada, EMEA, APAC, CSR (Customer Specific Requirements)
  • At least ten years of work related experience, of which a minimum of four years' experience in a related management role
  • General knowledge of the medical device industry
69

Quality Assurance Director Resume Examples & Samples

  • Develops and implements quality planning, inspection methods and defect prevention/corrective action processes for new and existing products
  • Directs and oversees the work of quality professionals supporting manufacturing and design assurance
  • Fosters employee development to prepare others to assume increased levels of responsibility
  • Manages Expiration dating inquiries and reprocessing systems
  • Demonstrated ability to achieve productivity goals without sacrificing quality in a manufacturing environment
  • Full working knowledge and experience with all development procedures and processes, including design control processes
  • Must be able to maintain confidentiality of information when required
  • Must be able to work with all levels of employees in a matrixed environment, including hourly production employees through senior management
70

Director, External Quality Assurance Resume Examples & Samples

  • Minimum of 10 years Industry experience
  • Previous or current supervisory / management experience
  • Previous experience in Sterile Manufacturing, (in either Tech Ops, Mfg or Quality), people management, Regulatory Inspections, and in managing significant investigations is required
71

Director Business Analysis & Quality Assurance Resume Examples & Samples

  • Directs and controls the activities of a functional IT area through one or more department managers within the company. Including strategic planning & goal setting to set the strategic direction of the group
  • Business Analysis planning, tracking and control - accountable for the planning and execution of IT Business Analysis efforts, ensuring projects and change requests are completed on time and BA processes are followed
  • Quality Assurance planning, tracking and control – accountable for the planning and execution of the IT Quality Assurance efforts, ensuring projects and change requests are completed on time and QA processes are followed
  • Overseeing the development and implementation of IT related training programs and documentation efforts. Responsible for ensuring the appropriate training and documentation needs are being met
  • Collaboration with other departments and management as necessary
  • Evaluating data, developing recommendations, gathering and organizing information and developing presentation materials for management reviews
  • Understanding GAF’s applications and the interdependencies with other corporate and external systems and gaining comprehensive and extensive knowledge of business processes, issues and data challenges
  • Overseeing the review process for business requirements, functional requirements use cases, workflow diagrams, interface designs, test plans, test scenarios, test cases etc
  • Leverage experience to recommend industry standard and best practice solutions
  • Fostering and ensuring collaboration with various IT teams to coordinate system changes and to ensure appropriate system testing
  • Facilitating meetings and monitoring action items
  • Providing guidance and leadership to the Business Analysis and Quality Assurance teams coaching, mentoring, reviewing work, setting schedules, etc. and supporting resources as they develop and maintain relationships with business leaders
  • Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems
  • Recruiting, motivating and developing a superior staff. Effectively managing a team that is customer focused, encouraging creativity, driving performance, and effectively developing and rewarding key performers
  • Defines, develops, and implements, along with IT management, department-wide strategic plans and objectives
  • Helps business operations utilize information systems to improve efficiency
  • Works with managers to guide the overall direction, strategy, and management of the group, its processes and portfolio of work
  • Regularly interacting with senior management, customers, vendors and industry consultants to define service and performance levels in order to improve customer satisfaction
  • Responsible for education on business analysis and quality assurance standards and assuring process compliance
  • 60%
  • 15%Communication and Collaboration – regular communication with regards to BA / QA / D&T issues, project status, and many other various topics. Creating miscellaneous presentations, metrics reports, process documentation, etc. Regular communication with the business. Facilitating weekly team meetings and collaborating with team members across IT and the business
  • 20%Development and institutionalization of Business Analysis, Quality Assurance and Documentation & Training methodologies, polices, procedures and metrics; manage and track; education, and process compliance
  • 5% Perform other duties as assigned
  • Advanced knowledge of and development / execution of IT Standards, Policies and Procedures
  • Intermediate knowledge of Emerging Technologies
  • Advanced knowledge of and development, review, and execution of SDLC
  • Intermediate knowledge of Information Security Awareness
  • Intermediate knowledge of General Project Management Methodology & Tools
  • Intermediate knowledge of GAF Systems, Applications, & Technologies
  • Intermediate knowledge of Application Design and Architecture
  • Very Strong knowledge of Business Analysis Best Practices, processes and methodologies
  • Strong Understanding of modeling capabilities to document use cases / test scenarios, data, processes and events
  • Strong Experience in providing guidance in the development of and reviewing BA defined deliverables e.g. Functional Requirements Documents, Business Requirement Documents, Use Cases, Swim Lanes, UI Design, etc
  • Advanced knowledge across functional areas – HR, Finance, Supply Chain, etc
  • Very Strong experience in business process design and re-engineering and workflow analysis
  • Strong understanding of basic web and client / server architectures
  • Strong experience with ERP applications; PeopleSoft preferred
  • Strong knowledge of QA Best Practices, processes and testing methodologies
  • Strong Understanding of Application, System, End to End and Regression Testing
  • Strong knowledge of System Testing tools; tracking within testing tool - test case documentation, execution status and defect reporting
  • Strong Experience in providing guidance in the development of and reviewing QA defined deliverables e.g. Test Plan, Test Scenarios and Test Cases
  • Strong experience in translating functional and non-functional requirements into test scenarios and test cases that align with business processes
  • Excellent ability to Multi Task
  • Very Strong Prioritization skills
  • Very Strong Analysis & Problem Solving Skills
  • Very Strong Adaptability
  • Very Strong Vendor Management Skills
  • Strong Budget Management Skills
  • Very Strong ability to develop new policies, procedures and processes to improve the operations of the team
  • Very Strong Time Management Skills
  • Excellent Drive for Results
  • Excellent Ability to Think Conceptually and Forward Thinking All of the Time
  • Excellent Ability to Influence and Drive Cross Functional Decisions and Initiatives
  • Highly motivated self-starter
  • Very Strong understanding of dependencies within an IT Organization
  • Strong credibility with management and IT team
  • Advanced general business knowledge
  • Demonstrated ability to oversee and provide direction to team members involved in projects covering multi-disciplines, ensuring quality and timeliness of BA / QA / D&T team deliverables
  • Master’s or Bachelor’s Degree in Computer Science, Information Systems, or other related field
  • 12+ years of IT and business/industry work experience
  • 9+ years of leadership, management and supervisory work experience
72

Director, Global Design Quality Assurance Resume Examples & Samples

  • Leads and manages all MS, LC, Chemistry and other applicable Global Design Quality Assurance responsibilities including the meeting of local design quality activities and initiatives
  • Manages Global Design Quality Assurance teams and employees and ensures all quality requirements and processes are incorporated into product development and sustaining product improvement processes
  • Development, implementation and monitoring of policies and procedures to ensure the highest levels of product quality, design quality and customer satisfaction while maintaining regulatory compliance
  • Leads the design quality assurance initiatives, provides direction and leadership, and ensures that company objectives and regulatory requirements are met
  • Engages, leads and collaborates with the development and sustaining teams in deploying new, or changes to existing, processes and systems to improve the overall effectiveness, efficiency and compliance of the Quality system in accordance with, but not limited to, the requirements of ISO 13485, EU IVDD, new IVDR, and regulatory requirements including 21 CFR 820, 93/42/EEC and 98/79/EC as applicable
  • Actively participates in the product development process and ensures best-in-class practices and scientific analyses are employed
  • Be an active contributor and knowledgeable, contributing member and represent Design Quality on all projects
  • Drives product risk management activities and leads mitigation assessments and implementation in compliance with ISO 14971
  • Supports usability engineering activities in compliance with ISO 62366
  • Works cross functionally and within Waters Global Quality to ensure activities and potential improvement work is aligned, harmonized and standardized
  • Ensures information relating to product quality and the quality system is communicated to relevant management and staff within Waters
  • Implementation of corrective and preventive actions to ensure compliance of the quality management system with applicable quality and regulatory standards
  • Participates and supports audit activities, both internal and external
  • Produces, tracks and trends quality metrics to deliver tangible improvements to the overall business
  • Manages department budgets and meets them
  • Leads and/or participates in other projects as assigned
  • Minimum of a Bachelor’s degree required
  • Advanced degree is preferred (in a life science or engineering discipline; PhD, M.S., MBA or equivalent)
  • Professional certification is strongly desired (e.g. ASQ certifications)
  • Minimum of 5 years in managing employees
  • Minimum of 7 years of experience leading Design Quality function within a disciplined industry such as medical device, pharma, Biotechnology, life sciences or similar discipline arena
  • Proven quality leadership in the design and execution of quality systems compliant to ISO 13485, 21 CFR 820, ISO 14971 and ISO 62366
  • Design Quality Assurance - Has an excellent technical proficiency in the knowledge of regulatory requirements and standards which impact the design, development and manufacture of products
  • Demonstrated capability of managing design quality assurance and product development activities and objectives to plan
  • Experience with Class I/II/III medical devices/systems and/or in-vitro diagnostics (IVD) experience is highly desired
  • Prior experience in a leadership role with overall responsibility for directing a Quality organization is required
  • Able to work effectively globally
  • S/he must have a strong understanding of design control and design quality requirements
  • S/he will have the ability to identify and analyze complex problems and recommend actions
  • This position will develop schedules, budgets and have a comprehensive understanding of business objectives
  • Able to effectively manage teams and projects/programs
  • S/he will have proven track record in a matrix environment, exceptional team building skills and demonstrated ability to direct activities from concept through to completion
  • Outstanding Work Ethic
  • Effective communication and influencing skills
  • High energy problem solver/achiever – Self Starter
  • Well-Organized and Detail-Oriented
  • Strong team orientation and team builder
  • Ability to mentor and development members of the team
  • Successful History of Achievement
  • Experienced International Business traveler
  • Business financial analytics experience
  • Demonstrate sound judgment/rationale
73

Director of Quality Assurance Resume Examples & Samples

  • Proven knowledge of FDA guidelines and GCP is required
  • Organizational and prioritizing capabilities
  • Computer skills with ability to use clinical trial databases, electronic data capture, MS Access or Excel
  • Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment
  • Interpersonal skills, detailed-oriented and meticulous
  • 7+ years of management and/or supervisory experience
  • 7+ years of quality assurance experience in a clinical research environment (i.e. Sponsor, CRO, or large investigative site)
  • Understanding of investigative site research requirements
  • 10+ years of global clinical research experience preferred
74

Director of Quality Assurance Resume Examples & Samples

  • Establishes quality and reliability standards by studying product and consumer requirements with other members of the Management Team, production operators, QA lab technicians, and engineering staff
  • Manages and maintains FSMA compliance
  • Establishes raw material standards in conjunction with the R&D Team to ensure product quality, consistency and performance. This is also in collaboration with the plant operation requirements. Working with suppliers to determining testing methods, procedures and testing equipment
  • Establishes and fine tunes in-process product inspection standards, manufacturing methods; developing testing methods and procedures
  • Establishes analytical standards for the disposition of finished product by developing evaluation tests, methods, and procedures
  • Establishes product quality documentation system by writing and updating quality assurance procedures and SOP's
  • Maintains product quality by enforcing quality assurance policies and procedures and government requirements and training methods
  • Prepares product and process quality reports and summarizing information and trends
  • Maintains quality assurance staff by recruiting, selecting, orienting, and training employees
  • Maintains quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results
  • Bachelor's degree in food science, microbiology, or other closely related field, or an equivalent combination of education and experience
  • 10+ years' experience in food or beverage operations and/or quality assurance management. Experience managing a team of quality assurance technicians preferred
  • Management of a high volume of inventory throughout multiple sites
  • Computer skills and knowledge of state-of-the-art lab equipment
  • HACCP, ISO, SQF or other food safety certification required
  • Food safety audit experience desired
  • Must be able and willing to travel up to 50-80% of the year
75

Director of Quality Assurance Resume Examples & Samples

  • Develop and oversee an effective quality management system to continuously identify opportunities for improvement while maintaining adherence to contract driven key performance requirements
  • Develop and deliver quality management and quality assurance training for all employees engaged in quality and performance monitoring
  • Monitor and evaluate the effectiveness of all areas of project operations and reports quality issues to project and unit management
  • Schedule, coordinate and report on both internal and external audit functions of the quality management system
  • Schedule and coordinate all the quality and performance monitoring activities of QA staff across the project
  • Produce the quality assurance and performance reports as required by contract and project operations
  • Attend project management meetings
  • A Bachelor’s Degree from an accredited college or university in related field, equivalent experience considered in lieu of degree Master’s degree preferred
76

Director of Quality Assurance Resume Examples & Samples

  • As a part of the site management team, provides business leadership and technical quality expertise to the Operation
  • As part of the site management team, develops the appropriate plans to support and meet the Corporate, Franchise, Region and Site operating Goals and Objectives
  • Ensures compliance with FDA’s Quality System Regulations, ISO 13485:2003 Medical Device Directive, Canadian Medical Device Regulations, and other applicable industry standards
  • Performs the duties of Management Representative for the quality systems at Mentor Texas, as defined in the appropriate Quality Manuals
  • Acts as liaison with the quality system registrar, FDA and BSI Notified Body
  • Implements and directs the use of Quality Engineering principles, tools and techniques to develop and optimize systems and processes that are aligned with the overall Company strategy and mission, driving continuous quality improvement
  • Leads the Quality Assurance staff, works with team members to generate career development plans, and provides coaching to address technical and leadership challenges
  • Coordinates and leads the site’s quality assurance strategy and its execution to ensure the production of quality products consistent with specifications, established standards, and in compliance with regulatory and industry standards
  • Develops and manages the Quality Operations strategy, leading the alignment across Mentor sites
  • Provides guidance to the Quality Engineering function in regards to reliability engineering, design control, product and process improvement efforts and product specification development
  • Builds cross-functional support through influence and persuasion in order to facilitate continuous product and process improvement
  • Partners across sites to learn about, develop, and implement best practices
  • Leads continuous quality improvements throughout the entire life cycle of Mentor products, including providing input into new product design and development, optimizing manufacturing for commercialized products, providing input into continuous improvement plans for sourced components, and leading customer-driven quality improvement teams
  • Is technically competent to evaluate design control/product validation activities and data to ensure that design control/validation activities and data are appropriately implemented and utilized to support desired objections and conclusions
  • Develops performance objectives for the Quality function based upon corporate and plant quality objectives. Has both the authority and responsibility to assure these goals are attained. Prioritizes goals for the QA/QE function to achieve deadlines
  • Responsible for developing, managing and executing the Quality budget including Cost Improvement and Capital Investment projects
  • Monitors the key quality performance measures and the corrective action results. Responsible for the CAPA and Non-Conforming Product systems and reporting on the results to management with executive responsibility; recommending and initiating appropriate corrective action as appropriate
  • Oversees the internal audit program that complies with regulations, Mentor policies and measures the effectiveness of the quality system
  • Serves as the site management representative as defined in the quality System Regulation and ISO 13485:2003
  • Directly responsible for hosting all external audit such as Medical Device Single Audit Program and OCP
  • Oversees the development of all new product and line extension launches
  • Manages QA personnel and resource allocation to meet QA objectives at the Mentor TX site
  • Bachelor's degree in an applied technical discipline
  • Based on education and or experience be able to provide appropriate technical input and review of design control and validation activities
  • Minimum of ten years of experience in a regulated field, supporting Manufacturing, Quality, and/or Compliance
  • Experience in other J&J franchises or external businesses operating in a regulated field is preferable
  • Prior management experience required
  • Medical device manufacturing experience required
77

Senior Director of Quality Assurance Resume Examples & Samples

  • You'll build methods for quantifying and tracking quality, both at the product level and client site level
  • Research/recommend/implement automated, repeatable test strategies that utilize best practices
  • Develop standard test plans, scenarios, scripts, and test procedures that can be utilized by BSA's (or other project team members)
  • Develop methods for determining product readiness prior to releases
  • You'll document, track, and project-manage software defects, using our bug tracking system (Jira)
  • You will maintain experienced product knowledge, including our product's various configurations in order to effectively test scenarios
  • Build and implement load testing strategies; monitor and evaluate changes to the product's performance
  • You'll collaborate with Development, Implementation, and Operations teams to establish quality throughout the organization
  • You'll assist with the review of software documentation and release notes to ensure technical accuracy, compliance, and completeness
  • May perform other duties/responsibilities as needed or assigned
78

Director of Quality Assurance Resume Examples & Samples

  • Assist the Program Director in the development and maintenance of written training materials for ongoing use at the OCDI Jr
  • Behaviorally trained licensed Ph.D or Psy.D. with experience working with OCD patients, specifically providing exposure and response prevention treatment
  • 2+ years of experience
  • Experience in supervision/training of trainees and program development
  • All employees must possess basic computer skills to use a variety of electronic or online systems for communication, clinical and administrative purposes
79

JV Quality Assurance Director Resume Examples & Samples

  • Establish/Set Standards and Expectations for how we conduct Quality Assurance across all projects within the JV
  • Meet staffing requirements and resource sharing, as necessary, between the projects within the JV
  • Providing standardized reporting for the Quality Assurance functional area
  • Accountable for the performance of QA personnel on all the JV projects
  • Ownership of all quality programs for the JV (QA, QC, Audit, etc) which includes planning, establishing, documenting, and maintaining the quality assurance program
  • For providing indoctrination and training of project staff and management as defined in the PQAP
  • Minimum 10 years’ experience in Quality Assurance, minimum 5 of which must have been on a project
  • Minimum 5 years’ experience in leadership/management role
  • Extensive familiarity with Quality Assurance Programs and processes
  • Bachelor’s Degree in Engineering, Physical Science, or related field
  • Certification(s) in: Quality Engineer (CQE), Quality Auditor (CQA), and/or ISO-9000 Auditor
  • Experience in developing and/or managing audit systems
  • Fiscal responsibility as required by the Joint Venture agreement
  • Customers, suppliers, JV Partners
  • Project Managers, project personnel, estimating personnel
  • Trades personnel, union business agents
  • Various work locations in both field and office
  • Travel as necessary
80

Director, Post-marketing Quality Assurance Resume Examples & Samples

  • Establish annual master audit plan based on prior risk assessment to define audit need and periodicity of local vendor audits
  • Manage and oversee all local vendor GxP audits and assessments, including but not limited to PV, REMS, GMP audits at Specialty Pharmacies, inpatient pharmacies, as well as REMS related data/IT vendor audits
  • Ensure business functions timely notify plans to outsource GxP activities in order to duly perform assessment and selection of new vendors/business partners
  • Assess and select contractors conducting audits on behalf of Actelion SSF and act as their contract giver
  • Ensure proper root cause analysis / CAPA follow-up of audit findings, involving relevant business units
  • Act as host to Global Quality Management (GQM) internal audits and license partner audits conducted at SSF and coordinate corresponding CAPAs with CAPA owners
81

Quality Assurance Director Resume Examples & Samples

  • Organizes, directs, manages, and coordinates various departments, programs, and services related to managing resources, assuring quality services, and managing cases
  • Collects, analyzes, and manages real-time performance improvement data
  • Coordinates activities and acts as liaison with Professional Review Organization (PRO)
  • Reviews and recommends contracts with PRO, insurance companies, and managed care organizations
  • Designs and implements program evaluations of all aspects of resource and quality management
  • Develops cooperative relationships with other hospitals and community agencies to pursue goals related to case management, utilization review, and quality care
  • Designs and reviews policies and procedures related to quality management such as methods of data collection, outcome performance measures, chart review procedures, case analysis methods, and critical pathways analysis
  • Provides consultation, feedback, and recommendations to service providers and staff on resource utilization and adherence to quality standards
  • Responds to inquiries related to quality and resource management issues from customers, staff, compliance agencies, and others
  • Directs and/or conducts appropriate research into methods to improve utilization of hospital and medical resources and methods to improve patient care
  • Compiles statistical data and writes narrative reports summarizing quality management findings
  • Directs review of patient records to determine need for admission and continued stay in hospital
  • Directs personnel engaged in quality assurance review of medical records
  • Involvement in planning, developing, implementing and directing Nursing Services, to work collaboratively, with other interdisciplinary members which include physical therapy, social services, activities, dietary and other administrative and business staff. Other duties may be assigned
82

Director of Quality Assurance Resume Examples & Samples

  • Bachelor’s degree. Engineering or Business Management preferred. Master’s Degree preferred
  • 10+ years of Manufacturing and Quality Assurance experience in Aerospace or other complex manufacturing industry with exacting/demanding requirements
  • AS9100 QMS knowledge and experience preferred
  • Demonstrated success at delivering superior business results through the effective execution of the Quality Management System
  • A solid compliance and regulatory background, including the administration of a Quality Management System
  • Possess Lean Manufacturing and / or Lean 6 Sigma skills and experience
  • Familiarity with advanced quality processes preferred, e.g. - PPAP/ APQP/PFMEA/8D or A3 problem solving
  • Overall knowledge, skills, and attributes reflecting: Leadership, Strategy Development, Financial Acumen, Negotiation Skills, Organization Skills, Communication Skills, Team Work, Creativity, and Visionary Forward Thinking
  • Accomplished in building positive relationships with co-workers, suppliers and customers
83

Director, Clinical Quality Assurance Resume Examples & Samples

  • Provides direction to the Clinical Quality Assurance (CQA) Operations and Systems Functions to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance to applicable regulations
  • Responsible for ensuring that a strategic audit plan is designed and implemented for the development of all company programs, and that the activities are conducted and reports written according to SOPs and regulations
  • Represents the company and may serve as Inspection Administrator during regulatory inspections, both internally and externally, and provides strategic organizational direction to assure that responses are timely and appropriate to maintain the company’s good standing with regulatory agencies
  • Oversees all GCP and GLP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity
  • Establishes and leads and/or provides strategic direction to cross functional working groups to identify and mitigate GCP/GLP quality and compliance issues with potential impact across multiple programs, sites, or functional groups within the company including ROW sites
  • Determines acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality
  • This position has overall responsibility for the ongoing development and operational success of the CQA function. This includes talent development and succession planning, resourcing and budgeting, and alignment of CQA initiatives, goals and activities with company goals
  • B.S. in Biology, Nursing, Pharmacy or related scientific field
  • Minimum of 10 years of increasingly responsibility in pharmaceutical, GCP-related Quality environment
  • Minimum 3+ years direct and indirect management level experience including senior level project planning/budget management
  • In-depth working knowledge of the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidances and Computer System Validation
  • Auditing Knowledge: Understands the overall audit process including design, conduct and reporting, and corrective action follow-up
  • Communication skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents
  • Project Management: Must be able to manage all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
  • Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members
  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 25% travel
  • Science Knowledge: Possess the necessary science education and knowledge to manage related clinical trials and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states