Director, Quality Control Resume Samples

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D Brakus

Della

Brakus

283 Boyle Crossroad

Philadelphia

+1 (555) 314 3091

283 Boyle Crossroad

Philadelphia

Phone

p +1 (555) 314 3091

Experience Experience

Philadelphia, PA

Director Quality Control

Philadelphia, PA

Breitenberg, Becker and Thiel

Philadelphia, PA

Director Quality Control

Providing microbiological expertise and support for product investigations, improvements, etc. to ensure continued compliance with regulations
Directing the development, planning, implementation and maintenance of QC test methods, processes and operations
Actively influencing the development and formalization of corporate laboratory control standards, policies and guidelines
Defining framework for department objectives, operation schedule, processes and budgets
Effectively leading Chemistry, Micro and Bio Chemistry teams supporting strong interactions with Manufacturing teams
Effectively interacting with other departments - other Quality groups (internal and external), Manufacturing Bulk and FF areas, MTS, Engineering, Materials, Finance and HR
Directing Quality Control Support Services (Validation, Analytical Methods and Training)

Houston, TX

Associate Director, Quality Control

Houston, TX

Ondricka, Dietrich and Klein

Houston, TX

Associate Director, Quality Control

Oversee service providers in accordance with quality agreements
Management of deviations, CAPA and change control as related to analytical methods and specifications
Approval of analytical test methods that progress from development to the commercial arena
Management of LIMS
Work with CMO and OTL to complete lot disposition
Responsible for OOS, lab and protocol deviations, Implement corrective action plans when necessary. Provide updates at daily and weekly meetings
Identify and resolve testing issues with service providers

present

Boston, MA

Senior Director, Quality Control

Boston, MA

Bechtelar Group

present

Boston, MA

Senior Director, Quality Control

present

Incorporate risk management principles into the management and decision making process, while promoting quality awareness and continuous improvement
Understands and proposes improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies
Quality Control and Systems Improvements with value-added focus
Keeps abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc
Development and maintenance of QC Policies & SOPs
Provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.)
Productivity & efficiency improvement

Education Education

Bachelor’s Degree in Chemistry

University of California, Los Angeles

Bachelor’s Degree in Chemistry

Skills Skills

Experience leading continuous improvement projects within QC laboratories
Experience with developing and implementing QC procedures and business processes
Experience supervising, mentoring, and developing staff, including managing multi-functional teams
Excellent skills in written and verbal communication of detailed technical information and research strategies, effective interpersonal skills in coordination and organization of internal and external resources for materials testing, and skilled in analysis of data and application of statistical tools
A strong understanding of protein chemistry, general protein analysis and characterization methods, method validation and transfer
Ability to establish and maintain quality systems and processes within Quality Control in compliance with ICH and cGMP regulations as well as corporate policies and directives
Experience directing Quality Control programs for method transfer, method validation, in-process testing, bulk drug substance testing, drug product testing and stability testing
Working understanding of test procedures with experience reviewing and approving validation protocols and reports, testing data, deviations, investigations and CAPAs, related technical reports
Experience interacting with and managing contract testing laboratories
Experience authoring and reviewing CMC sections of regulatory submissions, and addressing health authority requests for additional information

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Senior Director Quality Control Resume Examples & Samples

Define and implement the strategy of the BI Quality Control group
Lay out the strategic objectives thru which the strategy will be implemented and accomplished
Provide leadership for both strands of the Quality Control group: (a) Billing Standards Coordination (alignment with upstream data providers; safeguarding of key operating metric definitions) and (b) Data Integrity Coordination (audit strategy and implementation; data integrity management and resolution; special projects)
Drive innovation by launching automated products and methodologies that challenge existing boundaries and provide lasting solutions to persistent problems
Explain deeply technical and complicated issues to a non-technical C-level executive audience, conveying (a) what happened, (b) why it happened, (c) what is impacted (and what is not), (d) how it is being resolved, (e) steps that need to be taken to prevent recurrence of the issue
Present regular status updates upward on the Quality Control group’s recent accomplishments, upcoming milestones and risks/dependencies
Champion data governance within the broader Business Intelligence Group, on the company-wide Data Governance Council and throughout the entire enterprise
Exceptional communication skills (both written and verbal)
Superior people-management and leadership skills
Ability to succeed in a very ambiguous and unstructured environment
Ability to prioritize in the face of multiple demands
Ability to quickly learn new businesses and technologies
Strong background in applied math (experience with statistical audits/forecasts is a plus)
Experience with Six Sigma or other quality-management methodologies
Experience with/knowledge of SQL databases and BI reporting tools
Cable industry experience
Familiarity with billing vendors
Familiarity with MDM tools and methodology
Familiarity with BI-specific data quality monitoring tools and methodologies

Executive Director Quality Control Resume Examples & Samples

Lead the establishment of a robust strategy for Quality Control testing that enables testing of product to the highest standards as required by regulation
Leads the company Product Specification Committee establishing appropriate and robust product specifications
Represents the company at key Health Authority interactions as a company expert in CMC
Build a team of QC subject matter experts who partner with the business to address QC test needs
Ensure that Alexion Quality Control operations have the laboratory facilities, equipment and utilities appropriate to their needs. Work with the local site and quality management teams to ensure that testing infrastructure needs are identified, justified and presented for budget consideration
Provide strategic leadership to the Quality teams responsible for the testing of Alexion commercial and clinical products within Alexion
Develop formal programs to assess and improve Data Integrity across all analytical and microbiological laboratories at Alexion
Establish robust QC data review forums to review assay performance and create a culture of continuous improvement for all testing methodologies, utilizing and promoting new technologies where appropriate
Collaborate with cross-functional project teams to support QC activities necessary for the management of 3rd party CMO’s, as well as timing and strategies for method validation and method transfers
Develop and maintain strong and effective relationships with partners including Internal Manufacturing Facilities, Quality Assurance, Commercial Operations, Process Development, Regulatory Affairs, Human Resources, Legal and Finance leadership to insure corporate goals are met
Ensure robust measurement and reporting tools are developed across testing sites to enable accurate and timely reporting to senior management
Demonstrated abilities in the operation, validation, and on-going compliance of cGMP laboratory facilities
Demonstrated ability authoring and representing CMC content in global regulatory submissions
In-depth knowledge of bioanalytical methods, microbiological methods and stability requirements
Ability to organize and assimilate data/information and prepare strategies from it
Ability to see the big picture; to prepare contingency plans and future strategies; to be proactive; to initiate continuous improvement projects
Detailed knowledge of lean laboratory approaches
Demonstrated leadership skills in developing, motivating, and organizing high performing work groups in the biotechnology industry
Understanding of the budgeting process for QC and Quality operations
Excellent communication skills—both upwards and downwards and outside the company. Ability to lead and communicate orally, in written documents, and in formal presentations is required
The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives, and policies in a professional and responsible manner

Associate Director, Quality Control Resume Examples & Samples

Oversight of GMP analytical testing programs at Contract Manufacturing and Contract Research Organizations
Analytical life-cycle management including method enhancements and associated analytical method validations and method transfers
Generation and trending of analytical release data for commercial drug substances and drug products
Building efficient and sustainable relationships with contract laboratories
Compilation of analytical sections for Annual Product Reviews
Oversight of the reference standard and reference materials programs that support both pipeline and commercial activities
Management of out of specification and out of trend investigations and trending of release and stability data
Authorship and review of CMC sections in regulatory filings for various health authorities
Management of deviations, CAPA and change control as related to analytical methods and specifications
Approval of analytical test methods that progress from development to the commercial arena
Approval of release specifications
Management of LIMS
Support of external audits in the areas of analytical release testing as needed
BS or advanced degree in Chemistry/Biochemistry or related discipline with 10 years’ experience
Good understanding of ICH, FDA and USP guidelines is essential as is the ability to apply guidelines to various stages of pharmaceutical development and commercial operations
Excellent data analysis skills and ability to provide recommendations that impact the scientific and business goals of the company
Leadership skills and demonstrated ability to work in a productive and collaborative cross-functional manner
Strategic thinker with ability to plan and implement
A well-grounded foundation in a wide range of analytical methods such as NMR, UV and IR spectroscopy, mass spectrometry and physical testing methods
In depth knowledge and working experience of applying separation science including HPLC and GC
Experience with small molecules and peptides
Excellent organizational skill, the ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple activities with changing priorities
Management experience in a Quality Control environment leading small groups or large departments and ability to mentor junior staff
Superb organizational and communication skills, both verbal and written with the ability to facilitate meetings, conduct trainings as required and to present information in an advisory capacity
Strong interpersonal skills, building relationships, influencing internal and external organizations along with ability to resolve conflicts,
Critical thinking, problem solving and attention to detail
Experience in authoring SOPs, technical reports and CMC sections of regulatory filings
Ability to influence cross-functionally various functions at Ironwood
Knowledge of statistics as applied to the analysis of pharmaceutical QC data
Knowledge of statistical software such as JMPExperience working with CROs and CMOs in a virtual environment
Experience working with partners to support both commercial and clinical programs

Associate Director, Quality Control Resume Examples & Samples

Responsible for QC release and stability testing of GMP drug substances and drug product materials associated with global R&D and commercial programs, including development and implementation of stability programs and collaborative interactions with CMO/CTOs for scheduling and performance of testing
Responsible for the primary review and analyses of GMP test results, preparation of interim and final stability reports, development of investigation protocols and reports, preparation of summaries and other documents for communication with regulatory agencies. Participate and, as applicable, make presentations in both internal and external reviews, including regulatory discussions
Responsible for planning, documenting and conducting investigations of test results and test method issues, co-management of GMP test method life cycle with Analytical Development, and assist with technical planning activities for process and product development and commercial strategies
Responsible for technical assessment of methods for compliance to cGMP requirements, guidance documents, and analyses of critical quality attributes. Implement strategies for adding new GMP test methods and verify suitability for company materials
Lead the planning and execution of GMP sample management procedures, documenting transfers and facilitating material submission for release testing, stability studies and QA retains at CMO/CTOs. Responsible to maintain an inventory of controlled temperature shipping containers, provide shippers and monitor performance of units used to transfer APIs, product samples, and reference materials during manufacturing campaigns, release testing and stability study testing
Assist and monitor preparation, qualification, and provision of documented reference materials to CMO/CTOs for use in GMP testing procedures
Responsible to provide quality control review and technical evaluation of in-house R&D testing of GXP samples, and to contribute to development of controlled methods, practices and CMC systems
Responsible to provide QC assessment of raw materials for CMC functional groups, assist QA in evaluation laboratory investigations at CMOs for product development of vaccines
Responsible for the VBU clinical sample inventory for research use, for the aliquoting and maintenance of original and daughter aliquots, and for the distribution of sample material to internal and external research groups for assay performance. Responsible for establishing the documentation for aliquoting, training and supervising personnel, and performing the electronic recordkeeping for traceability of generated data with the original clinical trial database of information
A Bachelor of Science in biochemistry, pharmaceutical science or closely related field, and a minimum of 10 years of related experience in the pharmaceutical/biopharmaceutical industry or quality control environment. A thorough understanding of commercial QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred
A minimum of 5 years of leadership experience within a commercial GMP QC laboratory
Experience leading continuous improvement projects within QC laboratories
Experience with developing and implementing QC procedures and business processes
Experience supervising, mentoring, and developing staff, including managing multi-functional teams
Knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, and strong technical expertise in biochemical and analytical methods and instrumentation, and statistical methods for data analyses
Excellent skills in written and verbal communication of detailed technical information and research strategies, effective interpersonal skills in coordination and organization of internal and external resources for materials testing, and skilled in analysis of data and application of statistical tools

Associate Director, Quality Control Resume Examples & Samples

Bachelor’s Degree in life science, chemistry, or related discipline with 15+ years of relevant experience or advanced scientific degree such as MS or PhD with 10+ years of relevant experience
QC Chemistry and Biochemistry experience
1603695

Director, Quality Control Resume Examples & Samples

Responsible for leadership of QC functional areas that include: Chemistry (protein chemistry, immunochemistry), Sample Management, Data Management and Stability as well as oversight of Contract testing services used by Alexion in support of GMP Operations. Provide strategic and tactical leadership to the Quality organization ensuring the execution of responsibilities within the Quality System
Ensure the manufacture and testing of GMP products is performed in a safe, compliant manner, meeting the regulatory requirements defined in relevant health authority submissions, cGMPs as well as local Health and Safety requirements. In achieving this responsibility, assess local processes for compliance to Alexion Standards and Regulatory Standards as they are updated and amended
Manage a team of 4-7 direct reports at Associate Director, Manger and Supervisor levels, with overall responsibility for 30-40 indirect reports
Recruit, retain and develop QC talent responsible for the management of quality operations to ensure the compliance of commercial products
A minimum of 7 - 10 years of biopharmaceutical experience with accountability for cGMP QC Operations and Product Quality in a manufacturing plant
Deep knowledge of regulatory requirements and current guidance documents for QC in support of biopharmaceutical facilities
Planning and organizational skills are required to plan, execute and track commitments of Quality Control and to adjust to changing priorities
Active participation in regulatory inspections technically supporting Quality Control function
Good interpersonal skills, ability to influence and communicate well, both verbally and written
Demonstrated leadership in building a QC function
Represent Alexion Pharmaceuticals interests, objectives and policies in a responsible and professional manner

Director Quality Control Quality Assurance Resume Examples & Samples

Functions as the highest level Quality Assurance authority for the Product Supply-Consumer Care manufacturing plant by directing the development, preparation, and management of the QA/QC systems
Has overall responsibility for assuring the quality and regulatory compliance of all OTC, medical devices and cosmetic products produced at Cleveland, which is a strategic Product Supply manufacturing site serving the United States, Canada, Mexico and Brazil
Manages the overall operation of the Quality Department, including Raw Material and Packaging Supplier QA at the Cleveland site and directs, evaluates and develops staff in order to prepare them for higher-level positions
Functions as a key member of the Cleveland site management team with responsibility to assure quality and regulatory compliance of all activities including capital projects, new product introductions, and cost saving initiatives
Assures the development of, and adherence to, meaningful QA specifications for all raw materials, components, intermediates, and finished products
Assures compliance to Bayer HealthCare policies and directives and to FDA current Good Manufacturing Practices (cGMP's), DEA Regulations for controlled substances and agreed upon third party (customer) Quality Agreements
Provides QA approval systems for new products, trials, data reviews, and raw material changes, process changes, immediate container approvals, and other similar processes that require coordination with regulatory affairs, medical and other R&D functions at BHC Headquarters
Evaluates and authorizes release for sale all Cleveland produced products for both domestic and international distribution that are judged to meet corporate, divisional, and government regulatory requirements
Authorizes the quarantine, rejection, or re-work of those products found not to be in compliance with all requirements
Maintains QA classification and control of all materials used in production
Manages the major computerized QA release systems and archival batch records systems. These systems are indispensable for manufacturing, materials control, and distribution
Directs the auditing and monitoring of Cleveland production to ensure full cGMP compliance, including qualifications/validations and cleanliness and adequacy of packaging and manufacturing operations
Ensures adequate follow-up to all internal and external audit reports and findings to correct any deficiencies identified (e.g. FDA, TAC, 3rd Party Customer)
Manages all regulatory inspectional activity at the site (related to Quality) and assures proper communication during an inspection to Global BHC QA, Regional Management and 3rd party customers
Provides support to R&D in compilations of the Chemistry and Manufacturing Controls (CMC) sections of NDA, ANDA submissions
Prepares the plant for regulatory Pre-Approval Inspections necessary for new product approvals by the FDA
Provides analytical lab testing support and regulatory consulting service to the Tech Ops department as they work to optimize manufacturing processes, reduce production costs, and resolve technical problems
Manages the divisional stability program for long term studies
Develops, evaluates, and approves chemical and microbiological methods transfers
Develops new or improved test methods to increase efficiency and/or reduce testing costs
Provides technical support to Consumer Relations through investigation of consumer complaints and monitoring of complaint trends. Assists in complaint follow-up to consumers and regulatory agencies
Establishes and maintain a safe and healthy work environment in the quality department. Assures departmental compliance to Bayer safety standards and fully supports adherence to all OSHA and environmental regulations
Supports workforce diversity and company employee training and development programs
Assures that the plant is registered with the appropriate authorities and obtains the applicable licenses and permits

Director, Quality Control & Product Support Resume Examples & Samples

Direct all Quality Control and Product Support activities including planning, implementing, and managing technical performance to ensure quality and financial objectives are attained. Specific functional responsibility for all Inspection, Supplier QA, and Calibration
Direct the development and implementation of defined and specific standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products and supplied goods
Design and analyze inspection and testing processes, mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications
Support the QA internal and external audits, corrective action system,
Direct the establishment and maintenance of the measuring and test equipment calibration program, and inspection laboratories
Investigate product issues and develop innovative and practical solutions to complex technical and quality problems ensuring that corrective measures meet acceptable reliability standards. Include the processing of field failures and the administration of the Failure Reporting And Corrective Action System (FRACAS)
Participate in reviewing engineering designs to contribute quality requirements and considerations
Consult with executive management to develop and implement current and annual technical, schedule, quality, and financial objectives for the QA program(s) to ensure strategic business objectives are met. May also participate in the development of annual and long-term objectives for the organization
Ensure technical leadership and excellence is maintained by directing and participating in the planning, attraction, selection, retention, and development of the required management, professional, and technical talent
Must be able to establish and maintain excellent Customer and Government relations. Primary product related interface with Customer Quality and Engineering representatives
May act as delegate and spokesperson with executive management, program managers, technical staff, customers, and government regulators on significant matters
Oversee the development of and ensure the security of proprietary technology while maintaining the strict confidentiality of sensitive information
Responsible for ensuring all laws, regulations and other applicable obligations are observed wherever and whenever business is conducted on behalf of the Company. Responsible for ensuring work is accomplished in a safe manner in accordance with established operating procedures and practices
Typically requires a Bachelors, Masters or PhD in engineering or a related technical field as well as fifteen or more years of progressively complex QA experience with at least nine of those years having management responsibilities. May substitute equivalent experience in lieu of education
Must demonstrate a detailed and extensive working knowledge and understanding of QA principles, concepts, theories, regulations and practices
Extensive knowledge of ISO 9000 or AS9100 or similar quality system
Leadership skills including organizing, planning, scheduling and coordinating workloads to meet established deadlines and milestones
Must possess the ability to resolve complex technical and management issues
Strong verbal and written communication skills to accurately document, report and present findings
Experience in the A&D industry with UAV/RPA products preferred

Director Quality Control Resume Examples & Samples

Maintaining a safe, efficient, functional and compliant laboratory developed to the required standards in accordance with site and corporate guidelines
Providing microbiological expertise and support for product investigations, improvements, etc. to ensure continued compliance with regulations
Directing the development, planning, implementation and maintenance of QC test methods, processes and operations
Developing strategies and directing actions to continuously improve data management practices and test method reliability and repeatability assuring inspection readiness and on time release expectations
Overseeing complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis and risk assessments
Actively influencing the development and formalization of corporate laboratory control standards, policies and guidelines
Defining framework for department objectives, operation schedule, processes and budgets
Effectively leading Chemistry, Micro and Bio Chemistry teams supporting strong interactions with Manufacturing teams
Effectively interacting with other departments - other Quality groups (internal and external), Manufacturing Bulk and FF areas, MTS, Engineering, Materials, Finance and HR
Directing Quality Control Support Services (Validation, Analytical Methods and Training)
Ensuring compliance with all legal and business requirements and Genzyme policies and practices
Identifying the required resources and expertise, implementing the appropriate team/departmental structures and establishing the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement
Identifying and communicating risks in area of responsibility and across the site; creating strategies and plans to manage risk to the operations
Participating in development of site long range in line with the corporate Long Range Planning
Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
Bachelor's Degree in a science or technical field and10 years of experience in pharmaceuticals or a related industry with 8 years in management position or an equivalent combination of education and experience
Demonstrated operational excellence of laboratories including lean, 5S
Project management and statistical analysis experience
Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the department
Experienced in regulatory affairs and quality assurance
Strong working knowledge of laboratory information management systems (LIMS)
Ability to work in a team environment, facilitate a team approach and communicate effectively

Director Quality Control Resume Examples & Samples

Responsible for the development and implementation of policies and procedures for Laboratory Controls system to ensure compliance with regulatory requirements and industry standards
Oversee commercial product testing, including sampling plans, coordination of testing with contract testing laboratories, review of testing data, issuance of Certificate of Analysis
Oversee Stability program for commercial products: review and approve stability studies documentation, including change controls for product retest/expiry period changes, and conduct stability data trending
Collaborate with Quality Systems during product complaint investigations, as required
Manage product and raw material specifications program; define requirements for product retains program
Review and approval of contract testing laboratories procedures and test methods
Oversee test method transfer studies; responsible for approval of documentation (protocols, reports), and execution of method transfer studies
Collaborate with Analytical Development, provide input and review and approve method development and validation studies
Author and/or review CMC sections related to batch analyses, specifications, stability, raw materials, environmental monitoring, etc. in NDA, BLA (including annual reports and amendments)
Trend and monitor quality metrics related to laboratory controls system; contribute to Management Review Program
Contribute to the development of annual product reviews for all commercial products, in accordance with applicable regulations
Develop, mentor and coach personnel; develop individual and functional area goals
Contribute to the development and management of departmental budget
Review and approve out-of-specification investigations, including approval of retest plans
Bachelor’s degree or higher in Life Sciences, Chemistry, Biology, or related field
Minimum of 10 years of industry experience directing and managing Quality Control and the corresponding laboratory controls system in pharmaceutical/biotechnology industry
Experience interfacing directly with the FDA, and other regulatory agencies is required
Must possess a thorough knowledge of GMP guidelines and regulations, ICH guidelines, and regulatory compliance

Associate Director Quality Control Resume Examples & Samples

Ongoing leadership support of the OptumCare Quality Control organization within the Business Solution Office
Gathering, Understanding, and Managing a quality control program aligned to matrix partner business requirements, performance drivers and customer expectations
Providing guidance to matrix business partners by leveraging quality tools and data to identify top opportunities for improvement to drive Financial and Net Promoter results
Providing guidance to matrix business partners around all components of an effective quality management system
Setting the direction of the Quality Control program for OptumCare, and leading the organization to achieve and exceed key performance metrics related to the ongoing management of a Quality Control organization
Manages and is accountable for professional employees and/or supervisors
Sets team direction, resolves problems and provides guidance to members of own team
May oversee work activities of other supervisors
Fields and assesses voice of the customer feedback and/or requests to troubleshoot and correct problems
Gathers, Understands, or Manages stakeholders' business requirements, specifications, and/or needs Analyzes business process information (e.g., performance metrics; analytics) to identify key issues, trends, and potential root causes within managed team and drives to solutions
Works with relevant stakeholders (e.g., end users; SMEs; sponsors) to establish appropriate criteria and goals
Ensures obtained data and information are accurate and relevant to meet end users' needs
Identifies risks and opportunities associated with current processes
Provides operational instruction and guidance to business partners impacted by business process solutions (e.g., procedure; system; applications)
Develops and/or provides education to team in order to facilitate effective solution implementation
Obtains needed resources (e.g., different functional teams; subject matter experts; internal and/or external stakeholders) to implement business solutions
Communicates any identified defects with relevant stakeholders (e.g., project managers; business partners; IT) and/or facilitates appropriate adjustments
Provides input into and/or develop relevant policies, procedures, and/or work tools to support new or updated business processes
Reports to relevant stakeholders (e.g., business sponsors; constituents) on benefits, challenges, and progress of solution
Demonstrates understanding of basic process management and total quality management principles and methodologies (e.g., Six Sigma; Lean, BPQM)
Demonstrates understanding of basics of transaction monitoring (e.g., claims processing; eligibility transactions; customer installation)
Demonstrates understanding of relevant organizations' operations, products and applications, strategies, processes, and/or business priorities in order to build effective solutions
Develops, demonstrates, and continuously improves understanding of upstream and downstream impacts to partners of business process operations and solutions
Develops and manages to operational Budgets and Forecasting models
4-6 years prior experience in a transactions based operation
Prior knowledge / experience with account/transaction based products
4-6 years of experience within a matrix organization
2-4 years’ experience in Total Quality Management roles and understanding of principles and methodologies (e.g., Six Sigma; Lean, BPQM, Project Management)
Intermediate to Advanced skills in MS Office Products (Excel. PowerPoint, Word, Access)

Associate Director, Quality Control Resume Examples & Samples

Oversee service providers in accordance with quality agreements
Set timelines for testing and study execution
Manage data review for all products managed by the Release/Stability Team
Develop and/or refine the testing and data review programs to increase efficiency
Review release/stability data and generate COA’s
Serves as Commercial Quality Control representative to cross functional project teams
Bachelors or Master’s Degree in any Life Sciences, minimum 10+ years of biopharmaceutical experience
Previous industry experience in a regulated environment highly desirable
Minimum 7 years of direct managerial experience
Knowledge of cGMP regulations for US, Japan, EU and other markets
Effective time management, teamwork and collaboration
Strong verbal and written communication (including presentation) and customer management skills
Demonstrated ability to effectively organize and execute tasks
Demonstrates proficiency in negotiation and conflict resolution

Senior Director, Quality Control Resume Examples & Samples

Lead the stability team of Quality Control (QC) laboratories. The QC leads at each of our stability laboratories reports directly to this position
Develop and implement strategy for the Stability function
Drive testing and operating strategies to maximize the efficiency and effectiveness of the QC operations
Manage escalation issues or testing interruptions in conjunction with the local QC lead and site QA
Ensure strong budgetary management, both CAPEX and OPEX
Establish the implementation of new technologies and processes that forward our strategies to maximize productivity and reduce testing cycle time
Ensure a clear talent development strategy is implemented for the Stability team enabling career development, both technical and people leadership. Ensure we build new capabilities for the new product pipeline
Ensure scalable and flexible capacity utilization within Stability network, utilizing both internal and external laboratory capabilities to address both peaks and troughs in demand
Develop and deploy cost competitiveness focus and ensure the culture of continuous improvement is strong within the Stability network
Work with peers and the other Quality control team leaders globally to deploy and embed standardized processes through the centers of excellence
Lead Quality and Compliance responsibilities for their labs and have advanced knowledge of laboratory-related GMP regulatory requirements
Represent the Stability team QC in platform, PDMS or other leadership forums as required
A minimum of a Bachelor’s degree (or equivalent degree) in a Life Science is required
A Master’s degree in science or business is strongly preferred
A minimum of 10 years’ relevant professional experience in a highly regulated industry in required
Certification in Lean/Six Sigma is a plus
Previous laboratory management and/or equivalent supply chain experience (Operations/Quality management, etc.) is required
Prior experience managing stability laboratories is preferred
Knowledge of the business environment inside a quality organization across various roles is required
Strong leadership capabilities, in particular as a change agent, and ability to lead transformations to deliver higher performance is required
Proven track record working in and supporting a global matrix environment is required
Previous experience with budget and capacity planning (OPEX, CAPEX, headcount) is required
Ability to translate strategy to execution and drive the organization forward in executing and delivering results is required
Ability to resolve and manage operational and quality problems is required
Experience in Process Excellence (Design Excellence, Six Sigma) is highly preferred
This position will be based in Raritan, NJ or Titusville, NJ and may require between 25-35% travel depending on business needs. Please note: considerations will be made for other Janssen sites in New Jersey and Pennsylvania, however regular travel to the Raritan and Titusville sites will be expected on top of other travel requirements for position.Quality Control

Associate Director, Quality Control Resume Examples & Samples

Establish user requirements for purchase, qualification of Kite’s QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state
Work with CMO and OTL to complete lot disposition
Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Develop, revise and review SOPs
Responsible for Data trending, control charts and metrics

Senior Director, Quality Control Resume Examples & Samples

Responsible for ensuring that all investigational and commercial drug products manufactured for Ironwood are analytically tested in accordance with the requirements stated in applicable regulatory filings and in compliance with the cGMPs
As a senior Quality representative for the company responsibilities include being the primary interface with business and system related issues at contract manufacturing and laboratory organizations (CMO’s)
Develop the procedures and systems required by cGMPs, FDA Regulations/Guidance’s and Ironwood’s Policies, to monitor and control the quality of the drug substances and products
Incorporate risk management principles into the management and decision making process, while promoting quality awareness and continuous improvement
As a senior member of the Quality organization the individual with also be responsible for due diligence activity, enterprise risk management activity, and creating an environment of compliance and operational excellence
Mentor, coach, direct, lead, and motivate a team of professional, technical, and administrative staff in focused, collaborative and constructively coordinated execution of quality control duties. As it applies to investigational and commercial products, such duties include
Quality Control and Systems Improvements with value-added focus
Track record of successful internal and external regulatory audit findings
Proactive quality compliance while optimizing operational & financial measures
Managing budgets in excess of $2 million
Multi-site operations and/or diverse 3rd party contract laboratories & manufacturing experiences
Productivity & efficiency improvement
Strategic/tactical planning & leadership
Understanding the manufacture of solid orals, small molecules, and polypeptides
Training in root cause analysis, six sigma and/or corrective action and preventative action plans
Experience conducting due diligence activities
Formal risk management and operational excellence training

Director, Quality Control Management Resume Examples & Samples

Establishes the QCM Model
Defines and implements QC Methodology, Governance, & Standards
Design and governs the QCM Master Test Plans
Leads standardization of QC tools and methods
Develops and implements the Enterprise Test Automation Strategy
Partners with EA, Data Mgmt Svcs, Home, Lifestyle, Digital, and Enterprise Apps in defining and evolving the QC Future State
Ensure QC services support many of IT business services teams such as Home, Lifestyle, Ent. Apps, Digital and Infrastructure
Implements QC health check metrics and scorecard reporting on IT QC performance
Leads the decision on test tools and automation
Leads Quality and Performance Improvements across all IT processes
Works with the IT Strategy & Innovation team to design IT as a Business Future State and Strategy
Bachelor Degree in a business discipline or Computer Science
10 years information technology management experience
4+ years leading IT QC Programs
7+ years in IT testing
5+ years implementing automation test environments
MBA or Master’s degree
Understanding of Insurance Processing Environment
Strong business acumen of Assurant’s overall diverse product portfolio, customer base, systems requirements and business capabilities

Director, Quality Control Resume Examples & Samples

Provides leadership to personnel through effective goal setting, delegation, and communication
Aligns goals and metrics of the department with the Company’s goals, policies and strategies
Maintains quality assurance program to ensure conformity of purchased material and final products
Maintains the facility’s corrective and preventative action system (APRISe) and ensures timely reporting, verification, and closeout of issues, including root cause analysis
Acts as the focal with suppliers, customers, quality representatives, and company personnel to discuss and resolve quality problems as required
Primary contact for Defense and Commercial quality ad regulatory agencies/authorities (DLA, DCMA, FAA, EASA, CAAC, etc.)
Prepares for and represents the company during all U.S. Government, defense department, and customer quality audits (process, product and quality systems)
Experience and working knowledge with ISO 9001, AS 9100/9110, FAA 14 CFR Parts 21, 43, 65, 145 and EASA, as well as US Department of Defense regulations (FARs, DLADs, DFARs, etc.)
Maintains and ensures EHS system meets company requirements and conforms to applicable federal, state and local regulations and industry standards including international EHS standards (ISO 14001, OSHAS 18001, OSHA, EPA, USDOT, NFPA, CDC and company tracking)
Develop and perform hazard, risk and requirements analyses within the organization/facility
Ensures all necessary reports, (internal, customer, regulatory etc.) are properly prepared, processed, updated and maintained
Ensure Performs and maintains internal and external product, process and procedure audits to assure compliance to specified requirements, including planning and coordination of audit activities, schedules and reports
Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures and processes
Supports receiving, in-process, and final inspection activities and/or personnel to ensure product quality is maintained
Develop quality and safety plans for new, existing or revised materials and products to ensure quality and safety in accordance with company, customer, regulatory/industry requirements
Generates training materials and programs as required, and conducts training sessions to support Quality and EHS system
Develops policies and procedures to increase the efficiency and effectiveness of the maintenance/production efforts, maximizing product quality, reliability and safety, while lowering costs
Participate as team member, facilitator, or leader in various cross-functional problem solving, continuous improvement projects/events
Apply lean principles, tools and techniques to eliminate non-value added activities and improve workplace organization, quality, safety, visual communication, and general cleanliness and housekeeping
Initiate and support improvement activities involving inspection techniques, process/procedure methods, tooling, cost and other areas involved in the control of material, process and product quality
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work
Appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Bachelor of Arts degree (B.A.) or Bachelor of Science degree (B.S.) from four-year college or university; or 10 years related experience and/or training; or equivalent combination of education and experience
Aerospace/Aviation Defense and Commercial quality experience (customer and regulatory requirements, detail parts, assembly, special processes, inspection, assembly/test, repair/overhaul, etc.)
Minimum 7 years management experience
Five years’ experience in a 14 CFR 145 Repair Station
Strong interpersonal skills, knowledge, and application of industry tools and techniques
FAA mechanics certificate with airframe and power plant ratings, preferred
FAA inspection authorization, preferred
DAR or DER, preferred
ASQ certification as CQA, CQE, or CQM, preferred
Background in continuous improvement, preferred

Director, Quality Control Resume Examples & Samples

Must have proven interpersonal skills, and be able to direct the activities of subordinates with a wide range of skill levels
Well versed in the regulatory requirements (cGMP) of the pharmaceutical industry, and will have demonstrated strength in problem solving and resolution
Must have strong skills / experience with various types of laboratory testing techniques and instrumentation
Excellent computer and software skills
Excellent problem solving aptitude, communication and multi-tasking skills
B.S. / B.A. in Chemistry or related discipline with 10 years experience in pharmaceutical sciences or M.S. in Chemistry or other related discipline with 5 years of experience in pharmaceutical sciences
Minimum of 8 years of demonstrated excellence in chemical and/or pharmaceutical quality (cGMP) with an emphasis on Analytical Testing
Minimum of 5 years of supervisory or management experience

Risk Director Quality Control Resume Examples & Samples

10+ years experience gained from working in financial services industry
Risk management experience gained from working in financial services industry,
Previous experience in an audit and or testing function
Experience in an organization that is under strong regulatory oversight and scrutiny
Experience delivering a value added risk management program
Experience working with the regulatory agencies of publicly traded firms
Expert knowledge of internal controls and risk assessment
In-depth knowledge of Consumer Lending business processes and/or products and operations; regulatory requirements; and key processes, controls and exposure areas
Decisiveness and sound judgment on a consistent basis
Develop and maintain high impact relationships with senior executives
Influencing and conflict resolution skills
Proven leadership and management skills in a professional environment
Project management skills to support multiple complex assignments on behalf of various stakeholders
Proficient use of MS Word, MS Excel and PowerPoint and Visio

Director Quality Control Resume Examples & Samples

At least a Bachelor's degree in Chemistry
A minimum of 5-7 years experience in a pharmaceutical GMP environment
Experience with Empower 3 or ChemStation

Associate Director, Quality Control Resume Examples & Samples

Ensures corporate compliance to Regulatory Agency requirements (i.e. FDA,EU, DEA, etc.)
QA/QC Designee for US sites in the Corporate CQMS System (i.e., Trackwise) for all applicable Quality interactions (Deviations, Investigations, CAPA’s, etc.)
Leads, develops implements and maintains quality strategies, procedures and systems in line with corporate business goals. Ensures that quality strategies, procedures and systems provide assurance that the quality of products, processes and procedures are in compliance with all applicable regulations and continually improve laboratory quality systems and implement corrective actions as appropriate
Ensure that products and/or materials are being tested strictly under cGMP conditions and disposition is taken on time as per the committed monthly Production Plan and/or procedural requirements whilst continually improving to build efficiency into Quality processes to increase productivity
Ensure the integrity of data being generated through QC-IT Support by qualification/maintenance of software utilized by the laboratory of the Metrology groups (reliability of data generated-qualification/calibration/maintenance of instruments and equipment)
Actively participates and enforces Corporate Policies & Safety Policies to ensure departmental compliance with company requirements and minimize laboratory accidents
Actively participates in increasing the competencies of his direct reports as well as other associated employees within (Performance Review and Resource Development through Mentoring and Training, etc.) and outside Quality department (Quality Guidance) as well as holds ultimate responsibility for laboratory enforcement and applicable disciplinary actions

Director, Quality Control Resume Examples & Samples

Include the following. Other duties may be assigned
Evaluate personnel requirements of the quality control department
Confer with top management regarding quality control concerns preparatory to formulations of a fiscal budget
Schedule priorities for laboratory testing, review, and release for product release, stability, in-process testing, customer complaint testing, raw material testing, facilities testing, and component testing
Direct and administer stability program, including review and approval of stability data and reports prior to regulatory submissions and prior to initial marketing as well as the stability chamber maintenance and inventory
Provide direction for departmental training program
Investigate deviations from standard operating procedures and out-of-specification results within the analytical laboratory
Review and approve Validation Protocols and Reports (i.e. process validation and stability chamber qualification)
Review and approve Master Batch Records Quality Control section
Review and approve Label Copy Masters
Investigate out of trend stability results within the analytical laboratory
Investigate and trend excursions for the stability chambers
Review and approve QC laboratory data prior to finished product release
Provide direction in daily laboratory operations
Review and approve method validations and method transfers
Provide scientific support as required

Director Quality Control Analytical Chemistry Resume Examples & Samples

Provide scientific and operational leadership in the areas of cGMP-compliant biopharmaceutical testing services that include protein characterization, product and intermediate characterization, release testing, facility/utility testing, method validation, and potency testing
Provide effective leadership including: developing and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; assisting with Performance Calibration/Talent Pool Management; individual goal setting/performance reviews; managing the development of employees, training and development; quality and safety and supporting supervisors/managers in individual/department/business objectives
Provide technical expertise in the performance in the areas of responsibility and share with / transfer to the functional areas within the Bayer Biotech network
Possess a strong and current knowledge of cGMP compliance and maintain strong cGMP Compliance in the activities of the Chemistry function. Interfaces with regulators, inspectors and can interpret cGMP to solve technical issues using scientific compliant solutions. Familiarization with Quality Systems (OOS, CAPA, Deviations, etc.) and Data Integrity requirements
Work collaboratively with Bayer Supply Center functions and the Bayer Biotech network, to ensure that QC analytical methods are aligned with process needs/capabilities and product requirements. Identify and address technical and validation gaps in analytical methods and implement improvements in analytical methods per ICH requirements
Develop and implement operational excellence initiatives to increase productivity and quality, and decrease cost and cycle time
Identify and address potential problems related to the successful delivery of Chemistry and Infrastructure services
Address unanticipated issues and problems in an expedient, efficient and cost effective manner
Provide support to the functions of the Quality organization outside of areas of direct managerial and technical responsibility, with specific focus on the Bayer Biotech network. Work on abstract problems across functional areas of the business. Erroneous decisions will have a serious impact on the overall success of functional, divisional, or company operations. In addition, work independently on complex technical and managerial problems in which analysis of situations or data requires in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results
Master’s Degree in Science or Technical field
12 years of experience in Biotech with 10 years in management positions
Method development, biotechnology principles, protein characterization, biotech process (fermentation/bioreactor, purification and drug product), broad cGMP experience and knowledge of regulatory compliance, ability to interact with and gain the support of senior management
Skilled in achieving results and managing others to achieve functional/site/company objectives
PhD

Director Quality Control Resume Examples & Samples

Ensure compliance with all applicable US FDA, US DEA and EMA regulations and expectations related to laboratory operations. Anticipate and provide feedback to changes in such regulations and expectations and provide implementation strategy to the company to remain compliant. Ensure the QC laboratory is constantly inspection ready
Ensure compliance with all customer expectations related to laboratory operations. Maintain trusting relationships with customers such that they feel confident in laboratory operations performance and results
Be the primary contact for strategic decisions with company Corp internal customers, including Supply Chain, Production, and Quality Assurance. Maintain transparent, detailed and open communication with internal customers to permit continuous, easy identification of issue status and testing/release progress. Quickly identify, communicate and resolve issues which have a potential impact to deliver against commitments in a compliant manner
Work closely with the Client Andernach to develop best practices approach to laboratory related issues, to have a singular the Client approach which meets all existing customer expectations. Discuss new customer expectations such that the laboratory approach remains as consistent as possible across customers and products
Work with Quality Technical Services (QTS) group to ensure methods are validated and equipment is qualified to generate valid results. Coordinate improvements and harmonization of methods and equipment through QTS
Oversee quality and technical processes at contract laboratories and contractors / temporary staffperforming work on behalf of Quality Control, to ensure they are consistent with the Client standard
Lead and manage direct and indirect reportsto achieve the Client goals and objectives in a consistent manner. Foster the professional development of QC team members
Generate and maintain metrics to identify singular issues and trends for routine and non-routine work conducted in QC, including product performance, schedule adherence and laboratory performance issues
BS in Chemistry or other scientific field. MS or PhD in Analytical Chemistry preferred
At least 15 years in a Pharmaceutical Quality Control environment, at least 10 of those years managing people
Experience working for a Contract Manufacturing Organization or Contract Laboratory

Senior Director, Quality Control Resume Examples & Samples

Ensures contracted third-party testing (CMOs and Labs) are in compliance with appropriate quality practices to meet the desired quality attributes of the Company and ensures the facilities/quality systems will pass regulatory inspections
Development and maintenance of QC Policies & SOPs
Development and maintenance of specifications, reference standard and retains programs
Oversees method transfers and method validations at contract labs and CMOs
Provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.)
Reviews QC raw data from third parties, and generates Certificates of Analysis
Contributes to appropriate sections of Annual Product Reviews for applicable products
Authors QC-related sections (e.g., batch analysis, analytical methods, reference standard, and specifications) of regulatory filings
Keeps abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc
Participates in cGMP audits of contract testing labs
Supports corporate and third party inspection readiness activities
Serves as an SME for analytical methodologies, specifications, stability, reference standard, etc. during regulatory inspections
Understands and proposes improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies
Promotes a culture of total quality and operational excellence
Has experience working in a development, GMP and GLP environment as it applies to laboratory and stability functions and has experience in preparing and complying with required regulatory guidelines involving PAI and Inspection planning and follow-up
Experienced in analytical methods development and validation, method transfer activities, and continuous improvement. This will involve oversight of GMP testing at CROs and CMOs as it applies to laboratory and stability functions
Demonstrated ability to work in multi-disciplinary settings acting as facilitator and coach
Strong leadership, team building, organizational, communication and interpersonal skills
Has experience in overseeing and planning budgets and monitoring expenses. Provides direction on Goals and Objectives to support company strategic direction