Senior Manager, Quality Resume Samples

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L Auer

Lillian

Auer

7902 Streich Views

Philadelphia

+1 (555) 971 9141

7902 Streich Views

Philadelphia

Phone

p +1 (555) 971 9141

Experience Experience

San Francisco, CA

Senior Manager Quality

San Francisco, CA

Koch, Stoltenberg and Abernathy

San Francisco, CA

Senior Manager Quality

Assures quality products and processes by establishing and enforcing quality standards; testing methodologies; and establishing management routines
Collaborate with Business and Q&R Management to establish strategic plans and objectives
Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws
Lead quality product transfers, providing quality oversight of process optimization, Production and Quality support (troubleshooting)
Oversee and manage escalated investigations, ensuring robust corrective actions and expediting the alignment of the business to reverse adverse trends
Provide support during FDA, ANDA Holder, Internal, and Partner site inspections / audits
Establishes product quality documentation system by writing and updating quality assurance procedures

Boston, MA

Senior Manager, Quality

Boston, MA

Becker and Sons

Boston, MA

Senior Manager, Quality

Understand how all elements of the system software ecosystem work together and develop QA approaches that fit the overall strategy
Oversee the development and execution of test plans and monitor and report on test execution
Work with a team of quality engineering professionals to ensure the highest quality product delivery
Ensures team standards for quality service center are achieved and initiates improvement actions when necessary
Monitors and reports program performance against service level agreements and performance standards; initiating improvement actions when opportunities are identified. 6. Analyzes performance trends and takes proactive steps to prevent service shortcomings
Develops and conducts quality-related training
Represents the quality function to clients; serving as a point of contact for quality inquiries

present

Los Angeles, CA

Senior Manager, Quality CSV R&D

Los Angeles, CA

Oberbrunner, Emmerich and Hartmann

present

Los Angeles, CA

Senior Manager, Quality CSV R&D

present

Responsible for managing end-to-end programs/projects within the R&D space from a Q-CSV perspective
Proactively monitors processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
Utilizes knowledge of relevant Quality and Compliance areas to recommend existing solutions to business
Develops and communicates compelling, fact-based rationales that contain strong, logical arguments that build support for one’s perspectives and initiatives cross-functionally, and helps others to do the same
Responsible for managing budget for Q-CSV Program/Project/Base Business
Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
Utilizes expert knowledge regarding IT Quality risk management practices and leads and mentors a team through the system lifecycle

Education Education

Bachelor’s Degree in Science

Auburn University

Bachelor’s Degree in Science

Skills Skills

Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines
Thorough knowledge of applicable procedures, specifications, regulations and standards
Makes recommendation to Director, Quality for the release of clinical DS and DP product based on Quality Assurance record review and approval
Ability to attend to detail and work in a time-conscious and time-effective manner
Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems
Excellent organizational skills
Responsible for performing change control assessments and reviewing/approving change control implementation plans for tech transfer, new product introduction, and clinical DS and DP process or product changes
Provides direct supervision to QA Specialists including mentoring, performance management, staffing, budget management and project prioritization responsibilities
Good project management skills
Providing training to site personnel and contractors on GMP and the Quality System procedures

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Senior Manager, Quality Resume Examples & Samples

Work with business and development teams to understand product vision and requirements
Understand how all elements of the system software ecosystem work together and develop QA approaches that fit the overall strategy
Be responsible for development of test strategies and creation of appropriate test harnesses
Oversee the development and execution of test plans and monitor and report on test execution
Work with a team of quality engineering professionals to ensure the highest quality product delivery
Be an experienced but hands-on manager who can build an organization and ensure it performs
Bachelor’s degree in computer science, computer engineering or equivalent combination of technical education and experience
10+ years of industry experience, including at least 3 years of hands-on testing and 2 years as a manager
Experience in internet and wireless protocols, distributed systems design and testing required
Knowledge of QA concepts and methodology
Strong people management skills, with a proven ability to hire and grow talented programmatic and user-level personnel
Strong organizational skills, ability to track multiple test executions simultaneously and to be able to synthesize the results
Experience in agile development methodologies with continuous integration
Experience validating high quality consumer facing applications on embedded communications platforms
Experience with systems automating client / server testing with a heterogeneous mix of client applications and embedded devices

Senior Manager, Quality Resume Examples & Samples

50% - Support supplier quality engineers on programs as required to establish schedules and resolve complex technical or operational problems. Work with Supply Chain and engineering to identify, select and develop suppliers. Communicates product and quality requirements to the supplier quality assurance field engineers. Supports procured hardware documentation and acceptance review activities including First Articles and logbook reviews. Work with the suppliers in problem resolutions including the initiation and closure of root cause and corrective/preventative action. Ensures risks are properly documented, managed and mitigated
25% - Manages the day-to-day activities of the Supplier Quality Assurance (SQA) group. This may include, but is not limited to, activities such as determining organizational objectives and delegating assignments to direct reports. Interface with the Program Management office (PMO) and Supply Chain/Material Management (SC/MM) to establish priorities and assign personnel to meet those requirements. Manage budgets, logistics, and coordinating the continuing education/development of SQA personnel. Responsible for budget/salary planning and strategic initiatives/key objectives planning
25% - Support management by participating in proposal activities as requested/required. Work with SC/MM to develop and lead Supplier Management Teams. Facilitate continual improvement activities using the ARBOS tool set; develop supplier improvement methodologies and implementation plans
Technical degree and/or advanced degree
Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), and/or Certified Six Sigma Black Belt
Experience leading a Supplier Quality team in a multi-site manufacturing environment with track record of delivering quality performance improvements in supply chain

Senior Manager, Quality Resume Examples & Samples

Ensures team standards for quality service center are achieved and initiates improvement actions when necessary
Facilitates calibration activities and works collaboratively with training and contact center operations personnel to ensure consistency in quality service requirements
Monitors and reports program performance against service level agreements and performance standards; initiating improvement actions when opportunities are identified. 6. Analyzes performance trends and takes proactive steps to prevent service shortcomings
Develops and conducts quality-related training
Conducts process and product audits to confirm compliance with company policies
10- 12 years of related experience in call center monitoring; quality assurance; and/or customer service
US citizenship is required*

Senior Manager, Quality Resume Examples & Samples

Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements
QA Operations management lead support for Product Development, Tech Transfer and new product introduction activities for clinical DS and DP
Makes recommendation to Director, Quality for the release of clinical DS and DP product based on Quality Assurance record review and approval
Responsible for managing the review/approval of all manufacturing, testing documentation and support records for cell banks and clinical drug substance and drug product support to certify compliance with specifications and procedures; ensures timely resolution of documentation and quality system issues
Responsible for quality oversight for clinical DS & DP manufactured at CMO including partnering with Technical Manufacturing Services and global supply chain to ensure needs for Clinical studies met. Includes on-site quality oversight trips to CMOs and participating in business reviews at CMO sites
Reviews and assesses deviations; including performing risk assessments, participating in root-cause analysis investigations, tracking, follow-up, and reporting/trending
Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems
Responsible for performing change control assessments and reviewing/approving change control implementation plans for tech transfer, new product introduction, and clinical DS and DP process or product changes
Provides direct supervision to QA Specialists including mentoring, performance management, staffing, budget management and project prioritization responsibilities
Representing Quality Assurance to guide various project and technical meetings, as needed
Working with all departments to guide timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, Investigations, and Validation Activities
Providing training to site personnel and contractors on GMP and the Quality System procedures
Interacts effectively with Management and peers of company departments, external service vendors and, as needed, business partners
Minimum of 8 years experience in biopharmaceutical/pharmaceutical or related industry. Thorough knowledge of cGMPs, GLPs and regulatory requirements. Must also have 1 to 3 years of leadership experience; supervisory responsibilities for Quality group preferred
Demonstrated strong ability in problem solving, strong understanding of cGMPs, excellent interpersonal skills and the ability to prioritize multiple tasks. Uses a team-oriented approach to project management and problem resolution
Excellent understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations. Thorough knowledge of global regulations and thorough quality system experience (deviations, CAPAs, change control, validation concepts for pharmaceutical drug substance and drug product manufacturing)
Experience in leading and/or supporting GMP inspections by Health Authorities a plus
Demonstrated success in the development, implementation, and continuous improvement of systems, procedures, and processes to execute Quality Operations necessary to ensure GMP compliance
Demonstrated ability to lead GMP operations, make sound decisions regarding evaluation of GMP compliance, and leadership abilities, including mentoring and coaching of staff, in the management of QA oversight

Senior Manager Quality Resume Examples & Samples

Minimum of Bachelor’s degree or equivalent in Science, Pharmaceutical Science or a related field, a Master’s degree is preferred
At least 8 years’ experience in the area of Sterile manufacturing with a thorough understanding of pharmaceutical manufacturing operations, laboratory operations, and quality trends. Knowledge of Environmental Monitoring and/or Microbial Control is a distinct advantage
Must possess interpersonal skills, organizational skills, communication skills, time management skills and computer skills (particularly Microsoft Office and relevant computer packages e.g. Trackwise or similar)
Have extensive knowledge and understanding of worldwide requirements of cGMP and Quality Systems for Commercial and Clinical Injectable products. A previous focus on Data Integrity
Be a self- motivated individual with a desire to drive the highest quality standards and build a quality orientated culture
Ability to write scientific reports and technical correspondence, analyze problems and use lean tools to solve complex problems
Be fluent in the English Language and capable of efficiently communicating in both oral and written formats
Be comfortable working in a dynamic environment spanning a variety of time zones and cultures
Willingness to travel if and when required

Senior Manager Quality Industrial Resume Examples & Samples

Provide functional leadership for the regional Supplier & Product Quality teams; 11 direct reports globally
Drive improvement in supplier quality using lean methodology
Establish methods to communicate and align supply base to achieve quality objectives (quality contracts, supplier charge back, etc.)
Coordinate strategic supplier reviews and supplier audits
Engage with regional teams to improve chronic supplier performance
Align roles and responsibilities between supplier quality and the balance of the organization in order to optimize effectiveness
Facilitate establishment and roll out of standard procedures for all aspects of Supplier & Product Quality Management
Assess talent and resource needs & drive succession planning
Drive employee engagement & motivation
Develop training programs to improve skills of regional teams (Supplier Academy)
10 years of experience in operational leadership positions including quality, engineering, etc. preferred
Bachelor’s degree in technical discipline, engineering major preferred
Six Sigma Black Belt (Preferred) - Lean experience or certification desired
Demonstrated ability to implement proactive quality processes
Significant responsibilities for a supplier quality organization, regional and global - with the ability to work across cultures and geographies effectively
Ability to work well through all levels of the organization
Demonstrated Leadership and managerial skills around our TE values, such as Integrity, Strategy, Execution & Talent, Customer Passion, Teamwork, Accountability, Innovation and Edge
Demonstrated success leading teams to achieve goals
Ability to work in a fast paced, task-focused environment
Must be willing to travel up to 20% internationally

Senior Manager, Quality Resume Examples & Samples

Bachelor’s degree in Science and 14+ years of relevant Quality/Regulatory Affairs experience or Master’s/Doctoral degree and 12+ years of relevant Quality/ Regulatory experience; related experience includes 4+ years managing people
Demonstrated experience managing complaint handling activities in a regulated environment
Demonstrated experience organizing and generating Post Launch Risk Assessments (PLRA)
Ability to Coach, Supervise, and Manage personnel
Ability to drive results, foster teamwork, handle pressure, and provide feedback
Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations
Experience participating on cross functional teams
Able to apply business understanding and technical expertise to assist in solving complex technical and business issues. Able to make judgment calls using combination of knowledge of regulations, knowledge of technology, critical thinking, and interpretation of intent of the regulations
Ability to change the thinking of or gain acceptance of others in sensitive situations
Effective analytical and problem solving skills
Proven ability to work cross-functionally in a team based environment
Excellent leadership, organization, planning, and execution skills
Willingness to be flexible and adaptable to changing priorities
Proficient in MS Office Suite of products

Senior / Manager, Quality Resume Examples & Samples

Establish and Lead all QHSE Key initiatives and programs
Identify and manage QHSE Assurance and Governance in the Business Processes
Expand the FSG QHSE programs to suppliers and vendors
Expand the FSG QHSE programs to the service network
Drive the programs for the QHSE competency of the AP leadership and AP teams
Monitor and conduct systemic evaluation of Non-Conformance of QHSE principles
Develop tools and methodology to enhance QHSE standards
Provide guidance to the FSS team in supplier evaluation and performance
Enhance and monitor the quality metrics to promote QHSE objectives
Own and monitor the customer feedback process as part of the QHSE
Tracks and monitor of the performance of the FSS execution in established quality determinants
Support and tracks the Customer Registration for the FSS certification

Senior Manager Quality Work Systems Resume Examples & Samples

Driving the implementation strategy for KWS/QFS in Kellogg North America (KNA) as a Subject Matter Expert (SME) for the Quality Food Safety (QFS) Center of Excellence
Developing QFS KWS capability at all North American sites through effective development and implementation of train the trainers and coaching programs
Designing and implementing KWS QFS processes, KPI’s, tools, standards and align with a global focus on implementation of best practices
Influencing overall consumer and customer satisfaction by strategy of reducing or eliminating out of standard conditions
Integrating KNA QFS activities into KWS to ensure effective compliance and sustainable programs
Bachelor’s degree in food science, engineering or significant equivalent experience
Demonstrated strong problem solving skills including root cause analysis, risk assessment and corrective action
Substantial experience applying broad technical knowledge of quality and food safety in a food manufacturing environment; including operations, sanitation, food safety, materials management
Experience and technical capability to apply knowledge successfully across core Kellogg food categories and platforms e.g. cereal, toaster pastries, cereal bars, cookies, crackers and frozen foods
Current experience in leading continuous improvement teams within a food manufacturing environment

Senior Manager, Quality Resume Examples & Samples

Implement and supervise technical quality (i.e., adherence to client, regulatory agency, and company requirements), perform administrative functions (i.e., budgeting, forecasting, staffing, etc.), and help to maintain harmonious client relations
Communicate effectively with all labor grades, and contribute ideas that stimulate positive direction of business line personnel
Serve as project Quality Manager on medium to large projects, if necessary
Serve as the office Quality Manager, if necessary
Facilitate the implementation of the Operating System Requirements (OSR) in offices for which responsibility is allocated
Maintain relationships with key internal and external Clients and external Quality community

Senior Manager, Quality Resume Examples & Samples

Establishes and maintains Quality Assurance programs, procedures, and controls for the Receiving Inspection Department to ensure the performance and quality of products conform to established company and regulatory standards. Ensures that subordinates follow all company guidelines
Manages directly, or through subordinates, Quality Control support activities (Supplier Management, Receiving Inspection, and Calibration). Acts as advisor to subordinate staff to help meet established schedules or resolve technical or operational problems
Define and implement strategies to support and track continuous improvement and development of suppliers on Approved Supplier List.vi
Manage engineering team to perform quality system and process audits to evaluate potential or existing supplier capabilities and identify opportunities for improvement. Oversee supplier corrective action of identified quality and delivery concerns. Assure timely and effective resolution of concerns
Develop programs for supplier standards and methods for inspection, testing, and evaluation. Develop process to assist suppliers in developing statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes
Determines test equipment qualification, as well as requirements for testing procedures of raw materials, packaging materials, components and finished products
Plans, promotes, and organizes training activities related to product quality, reliability and regulatory compliance. Develops strategies to ensure continuous improvement in the ability efficiently move quality incoming products into production
Interfaces across the organization regarding identification and resolution of incoming quality problems
A minimum of 8 years of experience in, Quality Engineering, Quality Management, and/or Regulatory Compliance with in the medical device industry with 4-5 years’ experience in new product development required
Bachelor of Science degree in engineering or related sciences field required. Master’s degree a plus
In depth knowledge of domestic and international regulatory requirements (FDA, GMPs, and ISO/EN standards)
Good analytical skills, strong communication skills (verbal & written), excellent teamwork skills, creativity, high energy level, results orientation and project management skills are required
Excellent judgment and decision making capability in technical and compliance arenas
In depth knowledge of Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Industrial Statistical Methods and Lean Manufacturing
Strong leadership and proven track record of team development

Senior Manager, Quality Resume Examples & Samples

Maintain and improve the site’s Quality System policies and procedures to ensure full compliance with all applicable domestic and international regulations/standards
Serve as the site management representative and ensure the promotion of awareness of applicable regulatory and quality management system requirements throughout the organization, including top management
Serve as the primary point of contact regarding quality system requirements and compliance
Provide quality compliance consultation and mentoring to quality assurance staff and business personnel
Initiate quality programs, initiatives and activities to ensure the quality and reliability of products
Act as the site’s key person in all regulatory and quality audits
Ensure and monitor adequate training is performed and competency is maintained among all quality assurance department staff. Maintain personal competency in all aspects of quality systems, including policies and procedures
Serve as the primary point of contact regarding quality system requirements and compliance. Provide quality compliance consultation and mentoring to quality assurance staff and business personnel
Bachelor's degree (at a minimum) in a technical or scientific field
Quality certifications such as ASQ or Six Sigma certification is preferred
A minimum of 5 years’ experience working in a quality/compliance environment is required. A minimum of 2 years of demonstrated and verifiable direct or indirect leadership in directing the activities of complex teams is required
Experience with cGMP, FDA regulations such as 21CFR820 and ISO series of quality standards such as ISO 13485 is required. Direct experience with FDA and/or Notified Body inspections/audits is required
Excellent organization and time management skills is required
Effective verbal and written skills including the ability to collaborate and communicate effectively with all levels of management are required
Ability to be proactive, self-motivated and prioritize and multi-task in a fast paced environment is required. Strong interpersonal skills, including persuasion, objectivity, assertiveness, and thoroughness is required

Senior Manager, Quality Resume Examples & Samples

Responsible for the overall direction, coordination, implementation, execution, control and completion of Risk Management and other specific projects ensuring consistency with company strategy, commitments and goals
Write and prepare risk management strategy documents and risk management documents., including EU-Risk Management Plans and risk minimization plans for submission to regulatory agencies
Manage multiple portfolios of products/projects related to risk management
Review all risk management documents to ensure they meet regulatory requirements and facilitate review and sign-off
Organize and lead periodic review and assessment of Risk Management Plans
Oversee responses to requests from Regulatory Agencies for changes to risk management documents
Manage Risk Management project timelines
Create and maintain standardized departmental procedures for Risk Management activities
Strategically represent Risk Management on cross functional teams in support of Baxter products
Collaborate with Executive management and the Corporate office in developing and managing complex risk management documents
Ensure that Risk Management Plans and commitments are incorporated into project team plans
Interface with other Baxter groups as needed (e.g. Quality, Regulatory, Informatics, Business units, etc.)
Assist in the training and/or management of other team members
Leads the planning and implementation and sustaining of projects as assigned
Facilitates the definition of project scope, goals and deliverables; define project tasks and resource requirements; develops full-scale project plans
Assembles and coordinates project staff; manages project budgets; manages project resource allocation
Plans and schedules project timelines; tracks project deliverables using appropriate tools
Responsible for providing direction and support to project team and provide quality assurance; constantly monitors and reports on progress of the project to all stakeholders
Presents reports defining project progress and resolves problems and creates beneficial solutions
Implements and manages project changes and initiates interventions to achieve project outputs; provides project evaluations and assessment of results
Manage and participate in teams and committees as assigned
Knowledge of FDA risk management regulations
Experience with preparation of Risk Management’s regulatory submission documents (e.g. Risk Management Plans, briefing documents, etc.)
Clinical knowledge
Ability to read and analyze medical literature
Strong interpersonal/influencing/negotiation skills
Proficiency working in Windows-based work processing and medical/regulatory databases/resources
Strategic Planning and Problem Solving – Develop processes and standards to interpret and apply regulations, guidance and best practices
Scientific and Technical Analysis -Provide guidance to internal project teams in the area of design and analysis for more complex or high-risk projects
Risk Assessment Contingency Planning - Incorporate risk identification and contingency plans into PV activities
Knowledge and working application of reading and understanding blue prints, technical drawings and Standard Operating Procedures
Techniques and approaches to successful negotiation and ability to manage complex projects
Thorough knowledge of applicable procedures, specifications, regulations and standards
Knowledge and working application of FDA; cGMP; ISO requirements
Working knowledge of FDA Class 2 medical device regulations
The ability to work collaboratively with internal and external resources
Ability to manage/supervise a large team of employees
Must demonstrate strong MS Office skills, including Visio, Project, Excel, Power Point and Word
Provide leadership during stressful production demands; make decisions; solve problems; demonstrates team work and cooperation
Supports employee and team performance; provides new employee orientation; trains or provides adequate training for employees; coaches, counsels and motivates employees by setting a positive example
Evaluate employee’s performance and implement disciplinary action as needed in consultation with Human Resources
Supports and ensures effective employee relations; creates an ethical, non-discriminatory and safe work environment
Establishes effective communication lines/methods; identifies and solves employee problems; and manages conflict
Bachelor's degree in science or engineering; advance degree is helpful
7 years of experience in a Quality, Manufacturing, Engineering or related field
Risk Management experience is a plus
Exposure to working relationship with FDA and other regulatory authorities is desirable

Senior Manager Quality Resume Examples & Samples

Manage and coach a growing team of about 20 people (Bachelor/Master level, Quality Assurance, Quality Control)
Ensure released products are developed, manufactured, distributed and serviced at the right quality levels and comply with relevant regulations and Philips policies
Ensure Quality & Regulatory aspects are adequately covered in the selection, control and the monitoring of suppliers
Responsible to ensure the adequate release of incoming material, intermediate materials
Release of finished devices for clinical tests and delivery to customers
Decide on the course of action in case safety issues with products arise. In such cases, ensure adequate reporting to Authorities
Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement
Compliance, effectiveness and efficiency of the iso13485 certified QMS
Collaborate with Business and Q&R Management to establish strategic plans and objectives
Establish and track quality objectives
Work on issues that require in-depth knowledge of business processes and –objectives
Attract, develop and engage your team members

Senior Manager, Quality Resume Examples & Samples

Establish team metrics and goals for safety, quality, cost and delivery. Establish actions to achieve and exceed goals. Develop countermeasures for goals that are not met. Regularly evaluate and update goals and metrics for continual improvement. Drive metrics and goals within staff
Establish positive relationships with key customer quality contacts across multiple organizational levels. Build a customer interface contact list accessible to the department
Escalation point for tasks such as supporting Requests for PPAP and loading approved PPAP’s
Escalation point for tasks such as customer quality portal management, communicate customer portal complaints within TE, enter into TECHs, upload TE responses in portal, prepare and communicate customer quality reports
Escalation point for tasks such as customer notifications, PPAP, annual certification process, and customer complaints through CQE’s for key customers
Lead customer quality presentations VP Global Quality customer reviews with the support of operations and global quality counterparts
Regularly review customer scorecards, identify and address areas of opportunity within the organization
Be an expert on TE Quality documents/systems and actively communicate/coach TE employees directly or through staff
Be an advocate for quality proactively addressing needs and opportunities within the organization
Successfully negotiate on behalf of North American BU on customer issues
Identify opportunities for continual improvement of procedures, processes, and systems within the section and the quality organization
Develops solutions to problems of unusual complexity which require a high degree of ingenuity, creativity, and innovation
Develop talent of team members through activities such as technical training, people skills training, coaching, mentoring, and developmental assignments
Develop leadership capabilities of team members and create succession plan
Promote and advocate a safe work environment

Senior Manager, Quality Resume Examples & Samples

The appropriate organizational structure, resources, responsibilities and processes, policies, procedures, documents and records have been established and are maintained to meet the QMS requirements
The QMS is suitable for all operations including device design, manufacture, packaging, labeling, storage, installation, and servicing; and
The QMS is effective in maintaining the quality, safety and effectiveness of Baxter-Medina products
Ensures compliance with all applicable regulatory and corporate QMS requirements
Manages the QMS staff (including training and document control staff) and works closely with all other functions to maintain the suitability and effectiveness of the QMS
Ensures the proper review and approval of all new and revised QMS documents prior to issuance
Ensures QMS documents are reviewed periodically for adequacy or necessary updates
Manages the planning, execution, documentation of and required actions from periodic QMS Management Reviews
Establishes and maintains appropriate metrics and measures, including for document control, records management, change control and personnel training, and perform QMS data analyses in accordance with applicable procedures to identify issues and trends to initiate and execute corrective and preventive action where indicated
Coordinates internal quality audits and supports external quality audits, including regulatory inspections, as the QMS subject matter expert and through provision of document control and records management services
Ensures the efficiency, effectiveness and compliance of the document change control process, and that change control records/files are clear, concise and complete, and include documented premarket regulatory impact assessments where indicated
Ensures all records (hard copy and electronic) are appropriately identified, and stored in a controlled and secure manner, and are retrievable in a compliant, efficient and timely manner
Establishes controls to ensure training requirements are established and maintained and effectively completed for all personnel, including job-specific training, and training to address Baxter corporate, Baxter-Medina or departmental, Baxter corporate, or regulatory requirements including periodic QMS training
Manages the internal quality audit process to ensure audits are conducted when required by qualified individuals, corrective action is taken where necessary, audit results are documented and reported appropriately
Directly responsible for all quality inspection activities, including but not limited to in-process and final inspections
Makes determination as to acceptance of goods or products
Determines assignment of goods or products into quarantine area and subsequent disposition
Extensive knowledge of relevant FDA, Health Canada and other international regulatory QMS requirements
Demonstrated knowledge of current regulatory interpretations of QMS requirements and current industry best practices
Proficient in computer system use, including but not limited to Microsoft Office Suite and QMS software
Ability to manage/supervise a team of employees
Good communication and leadership skills
Good interpersonal/communication/influencing/negotiation skills
Certification by American Society for Quality (ASQ) as a Quality Engineer (CQE), Certified Manager of Quality/Operational Excellence (CMQ/OE), etc., preferred
BS degree in science or engineering
7 years experience in Quality, Manufacturing, Engineering or related field

Senior Manager, Quality Resume Examples & Samples

Drive resolution of product quality issues to improve product installation and reliability in new equipment and service
Support and improve process improvement for new equipment and modernization product and component change & development to prevent field turn backs and PUI’s (Product Upgrades and Improvements)
Support and improve process improvements and product quality issues to reduce factory and field rework costs
Coordinate and oversee efficient and timely closed loop execution of PUI’s
Support and drive the usage of the ACE operating system
Work with CLC’s (Contract Logistics Centers) on packaging, shipping, field installation manuals and field turn backs
Lead problem solving and root cause analysis to improve critical field-related metrics and absolute performance
Facilitate and schedule Passports as the Passport Champion
Serve as the PSO(Product Safety Officer)
Be a change agent to drive use of ACE in field locations both New Equipment and service
Drive simplification and standardization across the organization in Key Business processes
Facilitate & collaborate to resolution with WWE, WHQ, and Americas
5+ years field operations experience
Must be able to communicate effectively with wide variety of people with diverse backgrounds of all levels and disciplines
Excellent oral and written communication as well as impactful presentation skills
Project management / project lead experience
Must be able to facilitate change
Position will be located in Jupiter, FL. 50% travel, including willingness to travel throughout the Americas

Senior Manager, Quality Resume Examples & Samples

Bachelor Degree or higher in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience. Master's degree for qualification is desired
Audit experience preferred. Good knowledge of Singapore, US and European regulatory requirement
10 years or more of relevant experience in a quality assurance and other function (e.g. operations, technical, etc.) in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
Project management skill with good knowledge of system lifecycle management is preferred for the roll out of corporate automation system
Lean Expert
Lead and drive quality culture
Ability to build, develop and lead high performance team, good people management and team working ability with people at all levels
A continue improvement mindset
Demonstrates the ability to develop and promote an environment that nurtures creativity and improvement of current ways of doing things
Demonstrates active skill in challenging the status quo, offering practical alternatives
Demonstrates the ability to actively seek opportunities for improving department processes and increasing efficiency
Knowledge of systems and continuous improvement
Project management skill is preferred for the roll out of corporate automation system
Possess good knowledge and application of Lean with excellent problem solving skills

Senior Manager Quality Resume Examples & Samples

Assures quality products and processes by establishing and enforcing quality standards; testing methodologies; and establishing management routines
Establishes quality and reliability standards by studying product and consumer requirements with other members of management and team
Establishes product quality documentation system by writing and updating quality assurance procedures
Maintains quality assurance staff by recruiting, selecting, orienting, and training employees
Maintains quality assurance staff job results by coaching, counselling, and disciplining employees; planning, monitoring, and appraising job results
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies

Senior Manager, Quality Resume Examples & Samples

Manage a team of Quality Supervisors responsible for QC, exception handling and process audits to achieve release and compliance expectations. Responsible for the overall staff morale and culture of assigned areas
Ensure execution of company goals and objectives, policies and procedures (e.g., QSR/FDA, ISO and country regulations) and compliance to ISO 13485 , QSR , Medical Device Directive Requirements and any regulatory standards as applicable
Responsible for in-process Quality Operations function including proper implementation and execution of all pertinent Quality procedures. Identify opportunities for improvement and routine CAPA assessment
Work on projects of diverse scope requiring analysis of data, interpretation of regulations, assessment of implementation of policies and procedures, and root cause investigation in order to resolve compliance matter
Collaborate with global team to have common approach to compliance management and lead improvement initiatives across functional boundaries
Secondary Liaison for Edwards’ Regulatory and Corporate audits
Manage quality indicators for weekly/monthly/quarterly Quality System updates and review continuous improvement actions
Bachelor’s degree in Engineering or Science and 12 years of working experience within medical device or pharmaceutical industry required
Demonstrated track record in operations management required
Expert understanding of quality procedures while identifying applications of functional knowledge and existing methodologies to complex problems
Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of manufacturing to the business
Knowledge with US Quality Systems Regulation (21 CFR Part 820) , ISO13485 Quality Management System and ISO14971 is highly desirable
Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices preferred
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Lean Six Sigma Black Belt Certification preferred
Ability to process complex situation, “grey areas”, and work well under pressure
Able to lead and manage multiple tasks in a timely manner

Senior Manager, Quality CSV R&D Resume Examples & Samples

Responsible for managing end-to-end programs/projects within the R&D space from a Q-CSV perspective
Provide CSV guidance and support to project and/or base business teams in the resolution of validation documentation corrections and/or test defects
Utilizes knowledge of the assigned business functions to identify business needs and develop compliant solutions
Assist with incident management/CAPA and NC for the systems supported
Supports the allocation of resources by accurately communicating availability
Responsible for managing budget for Q-CSV Program/Project/Base Business
Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
Utilizes expert knowledge regarding IT Quality risk management practices and leads and mentors a team through the system lifecycle
Responsible for managing resources (both internal and external) and ensure availability for ongoing and upcoming initiatives/projects
Develops and communicates compelling, fact-based rationale that build support for one’s perspectives and initiatives cross-functionally, and helps others to do the same
Works collaboratively with project teams to keep them informed of project status, including any barriers
Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding Q-CSV policies, solutions and initiatives
Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
Partners with key stakeholders to assess, develop and implement solutions to meet their business need
Clearly communicates with Stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and when quality standards are not met
Develops and communicates compelling, fact-based rationales that contain strong, logical arguments that build support for one’s perspectives and initiatives cross-functionally, and helps others to do the same
Demonstrates an understanding of many relevant Quality and Compliance Principles and their applications
Utilizes knowledge of relevant Quality and Compliance areas to recommend existing solutions to business
Proactively monitors processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
Responsible for the development of direct reports by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs
Perform other work related duties as assigned

Senior Manager, Quality Resume Examples & Samples

Represent Quality from all functions (Engineering, Manufacturing, Procurement, Service, Category) in Tier 1-3 project core teams
Develop the Project House of Quality with support from the Continuous Improvement Manager, Category Manager, Product Development Manager and Project Lead to define customer requirements
Translate WDT quality targets to module targets and then develop improvement projects to support obtaining the target. This will require close interaction with product and process engineers throughout the design process
Develop the Product Quality Schedule and Deliverables Plan as input into the overall project schedule to drive completion with the support of the cross-functional quality teams
Have a clear understanding of triggers & timing of key quality deliverables throughout project and the C2C process
Drive Product Quality Previews to assess project risk at tollgates and determine functional "readiness"
Manage a Quality Action Register and drive resolution of issues on a timely basis escalating to the project core team and functional leadership as needed
Lead key quality improvement project teams for critical "NUD's" (New Unique Difficult changes)
Participate and support functional quality activities to ensure completion and escalate issue to core team. For example: 2P, DFMEA/PFMEA development, producibility reviews, Pre-pilot, pilot, safe launch
Participate in the planning and execution of testing including Engineering Field Test, Usability Testing, Consumer Use Field Tests and Internal Test Sales

Senior Manager, Quality Resume Examples & Samples

If defined on the Organizational Chart to Act as Alternate Management Representative in the absence of the Management Representative for the Quality System as defined in 21 CFR Part 82O, Subpart B 820.20b(3)
Ensure that processes needed for the quality management system are established, implemented and maintained
Report performance of the quality management system, including any need for improvement, to Executive Management
Ensure the promotion of awareness of regulatory and customer requirements throughout the organization
Coordinate all activities relative to obtaining desired certifications for operations, e.g., ISO 13485, ISO 9001 and ISO 14001 registration in the absence of the Management Representative. Act as the alternate ISO Management Representative, as required
Responsible for the management of key elements of the Quality Management System, including CAPA, Complaint Handling and Audits
Responsible for the management of the quality systems staff
Responsible for establishing the strategy for the quality systems program and for representing KARL STORZ Charlton on any regional or global harmonization efforts
Responsible for establishing goals and objectives and projects for the quality systems team and for coordinating efforts with the quality engineering staff, as applicable
Lead/participate in the supplier leadership efforts in conjunction with the supply chain/materials team, focused on key supplier development based on current and historical metrics such as quality and on-time delivery
Analyze and respond to CAPA thresholds and work with the various cross-functional teams to resolve issues
Provide training and lead supplier audits, when necessary
Function as department supervisor on occasion of the Director’s absence
Support lean manufacturing and continuous improvement efforts, including in-sourcing projects, waste reduction efforts, inventory reduction efforts, etc
Evaluate changes in products per organizational risk management practices to ensure effective, safe and complaint devices are released to the market in accordance with current state and federal standards
Internal Audits (planning, training, scheduling, conducting)
Coordination of 3rd Party Audits (planning, communication, issuance of findings, follow-up for effectiveness)
Coordination of Supplier Audits (planning, training, scheduling with QE’s, conducting, issuing findings, following-up for effectiveness)
Supplier Leadership Team Standard Work (Data review/analysis for supplier risk levels, RIS completion, quarterly scorecard communication verification, probationary/new supplier status, expiring ISO Certificates)
Corrective and Preventive Action System; As issues identified (via audits, internal notification, incidents, supplier issue, etc.) document the finding/incident, issue formal reports, document responses, follow-up on action completion and effectiveness, maintain systems/logs
Warranty Review Data (log maintenance, trending/analysis, recommended actions to the business)
Complaint Handling Data (log maintenance, trending/analysis, recommended actions to the business)
Inter-Site Return Process and Data (log maintenance, trending/analysis, recommended actions to the business)
Non-Conforming Material Report Data (log maintenance, trending/analysis, recommended actions to the business, issuance of SCARs for supplier caused trends)
Management Review Data (Excel spreadsheet maintenance, end of year archiving and file reset, overall analytical input for VICP, file review and follow-up on incomplete, inaccurate information.)
Oversight of RIS (Request for Initial Samples) Process and Data (trending/analysis, ensuring new components make it through the process when required)

Senior Manager Quality Contol Resume Examples & Samples

Bachelor or Master degree, preferably in bio chemistry or biomedical engineering
At least 5 year experience in manufacturing and quality control in in vitro diagnostic medical device industry or other regulated industry (e.g. medical device, or pharma)
Experience with leading and motivating a team and improving team performance Knowledge of or experience with Medical Device Quality Management Systems based on ISO-13485 and FDA Quality System Regulation is preferred
Team player, communicator, analytical and persistent and able to work in highly dynamic multidisciplinary environment, motivating people at all levels in the organization
Self-managed, structural planning of activities, deliver on commitments

Senior Manager, Quality Resume Examples & Samples

Preparation and reporting on the performance of the Quality System to Management with executive responsibility
Ensure Quality Systems are robust to ensure acceptable product quality is produced and released
Implement strategic imperatives set at a corporate level in the Rochester manufacturing operation
Lead a core team comprising of the following functions including; Analytics, Microbiology, Manufacturing Quality & Quality systems
Oversee product Quality that meets regulatory and customer requirements
Assess & challenge established Quality Systems and Quality Methods with an objective to improve overall system effectiveness, reduce product and process risk, and improve quality systems efficiencies. Development of efficient and compliant systems that meets both business needs and regulatory requirements
Apply both a Lean & Six Sigma approach in developing new or revised systems
Conduct problem solving investigation, root cause and risk reduction/mitigation across processes
Manage department budgets and headcount
Maintain applicable certifications & governmental body approval
Represent the quality function as part of the senior management & play a part in the strategic decision making at a plant level/

Senior Manager Quality Resume Examples & Samples

Ensure all cGMP/cGDP requirements are fulfilled for the supply of products (active substances for medicinal products for human use and, medicinal products) in accordance with country requirements
Manage the process that develops, establishes, and maintains quality assurance programs, policies, process, procedures and controls ensuring that performance and quality of finished products (active substances for medicinal products for human use and medicinal products) in accordance with Good Distribution Practices requirements
Identify, develop and execute quality plans and project timelines to meet group, site and company goals
Oversee quality activities related to the distributors and distribution center (receipt, storage, re-labeling (where applicable), distribution, returns,)
Manage the quality activities related to quality agreements and other customer requests
Lead strategic quality efforts for projects identified by the business unit/region
Participate in compliance audits and respond to audit observations
Serves as auditor for supplier quality audits and internal audits
Act as site Quality subject matter expert for regulatory agencies and corporate interfaces
Lead/Host regulatory inspection and respond to inspection observations
Will interact with corporate support groups to drive quality programs
Serve as cGMP/cGDP compliance subject matter expert
Complete technical and other quality duties as assigned
Minimum of 8 years pharmaceutical and/or related medical devices experience
Previous management level experience
Thorough knowledge of cGMPs/cGDPs for APIs and medicinal products requirements
Must be proficient at technical and compliance understanding of quality processes associated with quality, CAPA, deviations/exceptions, root cause analysis, change control and quality concepts in a distribution center/commercial office environment
Independent, self-starter who needs little guidance or follow-up once projects/tasks are assigned
Proficient at multi-tasking, well organized and reliable for consistent decision making and follow through
Demonstrated auditing and corrective action proficiency
Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues
Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment. Excellent problem solving and decision making skills
Ability to manage and drive change
Knowledge of document management/quality systems
Direct experience with Regulatory inspection highly preferred
Spanish writing/speaking
Interpretive skills and discernment in the application of global quality models and regulations to a wide variety of specific quality attainment settings
Ability to matrix manage projects with multiple functional groups without direct reporting authority
Getting work done through others that are not direct reports
Operates with minimal direction, self-starter
Building relationships with other departments
Interviewing and presentation skills
Statistical Analysis capability

Senior Manager, Quality Resume Examples & Samples

Act as a Quality Champion within the region supporting the development and cultivation of a Culture of Personal Quality within the organization
Oversee the approval of objectives, policies, and programs to support the CCS Business Unit Quality Strategy. Monitor metrics and direct activities to assure continuous progress towards achieving defined objectives
Ensure that the requirements and needs of the customer are clearly understood and defined. Coordinate the activities of all regional locations internal to the Business Unit, so that these needs are uniformly satisfied and that the source of the products or services is transparent to the customer
Direct the Business Unit’s Quality Programs and procedures to improve cost reduction and enhance efficiency
Provide the resources/training for the use and deployment of applicable quality tools within all levels and all groups of the organization to promote a strong Quality culture across the entire organization and to promote a fact-based decision making process
Develop and maintain effective Quality information systems that communicate key Quality related information and performance. Reports should be timely, thorough, and provide sufficient analysis or recommendations that appropriate actions may be taken. Establish and communicate minimum standards of product, process, and service levels for all locations in the region
Coach, mentor and lead highly dynamic team members to help achieve the requirements of this position as well as the individual career goals of team members
Working knowledge of ISO/TL 9000 Quality Management System Standards
5 years or more of previous Quality Management experience, preferably within a multi-plant manufacturing environment
Excellent communication and interpersonal skills. Ability to work effectively with all operational and functional areas and across international/cultural boundaries
Ability to drive change where required

Senior Manager, Quality Resume Examples & Samples

Develops and executes quality vision and provides direction and guidance on quality initiatives and policies
Develops key strategies for the business including all aspects of the quality including the audit process
Oversees the policies and procedures to insure the public safety, product quality and compliance of OTC Drug, Beauty, Health & Wellness and Fashion & Home Products produced by New Avon’s Supply Chain and Contract Manufacturers which are distributed across the United States, Puerto Rico and Canada
Works in close partnership with Marketing, Development groups, Sourcing, internal and external Manufacturing, Distribution, Sales and Customer Insight Center quality performance and improvement activities
Bachelor's degree preferred in a technical field, i.e. engineering or science. Master's degree is preferred. Supply Chain/Quality related certifications are a plus
10 plus years of progressive experience in Quality Assurance roles
5+ years of experience leading and overseeing quality assurance work
Must have experience working with contract manufacturers, managing new items to market and experience in OTC manufacturing and laboratory operations
Must have demonstrated project management experience with sustainable improvements
Must be able to effectively communicate, make independent decisions, have proven experience leading change and be aggressive about taking responsibility
Must be well versed in compliance requirements (i.e. FDA, Health Canada, cGMP, etc.)
Must have demonstrated auditing capability
Demonstrated ability to deliver strong execution and show sustainable improvements, and have the ability to work effectively in a team environment
Excellent written/verbal communication and effective listening skills
Ability to think outside of the box and challenge the status quo
Must be able to make fact base decisions and think strategically
Demonstrate and have proven experience leading employees
Must be able to lead / influence others in the development and implementation of business objectives
Must be able to analyze data and have operational understanding to identify, prevent, and solve problems and make decisions in a timely manner
Must be able to make immediate decisions with limited information and rapid assimilation of facts
Must have the ability to multi-task and take on multiple projects at one time
Must be able to travel. Travel may be up to 20%

Senior Manager, Quality IT Systems Resume Examples & Samples

Partner with functional teams to identify and implement optimal system designs
Monitor new technologies to identify state of the art systems opportunities
Partner with ICU Medical IT to assure appropriate infrastructures are in place to support all quality systems
Provide support to sites during regulatory and customer audits of the quality system
Interface with sites and functions to design and manage systems to elevate quality issues and drive corrective actions
Monitor regulatory environment changes relevant to storing and maintaining information, to interpret the effect of those changes on ICU Medical in setting up new processes and revising current procedures
Establish and implement business strategies with a longer-term focus (typically 3 to 5 years) based on the organization’s vision
Manage communications and negotiate matters of great importance having long-term, strategic implications for the whole organization
Develop truly new concepts or methods that break new ground
Analyze key IT infrastructure systems needed to support global quality systems
Well-developed interpersonal skills in order to motivate and lead the business as well as cross-divisional teams
Ability to mediate and negotiate with peers, customers, consultants, suppliers, and management of functions
Excellent written and verbal communication skills with the ability to communicate with all levels of professional and technical management
Strong presentation skills both internal and external
Bachelor’s degree from an accredited college or university; Master’s degree is preferred
Minimum 7 years of related experience
Must pass pre-employment drug screen and background check

Senior Manager Quality Resume Examples & Samples

Oversees, directs, coordinates, and prioritizes the daily activities of the Complaint Department within Quality Assurance
Manages the receipt, categorization and reconciliation of complaints through the designated software system. Communicates discrepancies to both internal and external customers
Identify complaints requiring notification of outside regulatory agencies and alert management in an expeditious manner of the receipt of such complaints in accordance with SOP requirements
Ensure samples are requested in support of complaint investigations, when required to thoroughly investigate the complaint. Support the complaint department with sample movement through the investigation including but not limited to documenting the information received through interviews with parties impacted by the complaint submission, documenting the information received from submitted documentation and field samples, submitting samples to the Quality Control laboratory for analysis, sending samples out to outside vendors for analysis, requesting information for various departments to support the complaint investigation and coordinating the complaint investigation with impacted departments, including other Actavis sites and contract vendors
Support Production and Laboratory area management concerning deviations initiated due to a complaint submission. Review complaints/incidents/discrepancies/trends and evaluate need for deviation initiation. Review, revise, and author deviation investigation reports and interim reports with production and lab deviations associated with complaints, ensuring compliance with cGMP’s, SOP’s, and FDA guidelines and requirements. Provide oversight / development for Customer Product Complaints (processing to completion)
Ensure comprehensive deviation root cause analysis and quality impact assessment. Evaluate impact and recommend disposition of product/batches involved. Provide concurrence and implement appropriate corrective and preventative actions to prevent similar occurrences
Ensure accurate reporting of site metrics related to complaints and field alert reports. Prepare metric reports in support of Annual Product Reports (APRs) and internal meetings (QRB). Ensure APRs are completed and approved in a timely manner per the approved schedule
Provide support during FDA, ANDA Holder, Internal, and Partner site inspections / audits
Support IT related system-based applications for QUMAS, QAD & Trackwise as it relates to job function
Support Supply Chain and QA Batch Release departments to ensure timely release of batches impacted by deviations to support customer service objectives
Assess departmental needs, identify opportunities for improvement, and implement
BS/BA preferred in Science or related field
5 to 7 years of experience in Quality Assurance and/or Pharmaceutical industry (Preferably, Solid Oral Dose)
A minimum of 3 years of experience leading or participating in pharmaceutical investigations or complaint handling
Experience in authoring or approving complaint investigations, protocols, SOPs, and/or Field Alert Reports is required