Our Client is seeking a Director of Quality Control (QC) who will provide strategic leadership in managing a growing team of scientists responsible for QC-related activities and operations. This individual will be responsible for providing scientific leadership, defining QC strategy and determining a roadmap for QC related activities and operations to meet corporate objectives. The scope of this role covers all phases of product development (clinical and commercial) for both large and small molecule programs.
Responsibilities
Lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP products
Lead and manage QC staff including hiring, developing, evaluating and goal setting
Oversee GMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf life determination
Oversee Quality Control requirements for compliance with cGMP regulations at external contract manufacturing and testing organizations
Oversee product release and stability specification setting and COA generation
Oversee and approve release of QC components of GMP manufacturing batch and test records at external contract organizations
Develop Quality Control strategy and direction in conjunction with the development of analytical methods and manufacturing processes by the Technical Development teams
Partner with internal and external stakeholders to transfer, qualify and validate analytical methods
Establish and maintain quality control standards applicable to the clinical and commercial product phases
Author/review relevant sections of regulatory filing reports and submissions
Drive continuous improvement projects in collaboration with internal and external stakeholders
Education and Experience Required
MS or PhD in Analytical Chemistry or a related scientific field
10+ years Quality Control experience is required, preferably with both small molecules and biologics
Strong knowledge of GMPs, ICH guidelines and Quality management systems
Experience with technology transfer to third parties
Experience with regulatory authority meetings and GMP site inspections
Extensive experience with analytical method development and validation
Expertise with stability testing, data trending and expiry setting strategy
Experience with testing injectable and oral dosage forms preferred
Experience in big pharma/biotech; experience in a startup biopharma company is desirable
Proficien.cy in MS Office, Word and Excel; statistical analysis software is desirable
Behavioral Competencies Required
Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with third party contract organizations
Excellent written and oral communication skills with a proven track record of developing employees
Self‑motivated and detail‑oriented, with the highest integrity
Other Responsibilities
Occasionally required to travel overnight
Ability to travel 10% of the time
Supervisory Responsibilities
Management and supervision of a small team and contractor(s)
Responsibilities may include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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Responsibilities
Lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP products
Lead and manage QC staff including hiring, developing, evaluating and goal setting
Oversee GMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf life determination
Oversee Quality Control requirements for compliance with cGMP regulations at external contract manufacturing and testing organizations
Oversee product release and stability specification setting and COA generation
Oversee and approve release of QC components of GMP manufacturing batch and test records at external contract organizations
Develop Quality Control strategy and direction in conjunction with the development of analytical methods and manufacturing processes by the Technical Development teams
Partner with internal and external stakeholders to transfer, qualify and validate analytical methods
Establish and maintain quality control standards applicable to the clinical and commercial product phases
Author/review relevant sections of regulatory filing reports and submissions
Drive continuous improvement projects in collaboration with internal and external stakeholders
Education and Experience Required
MS or PhD in Analytical Chemistry or a related scientific field
10+ years Quality Control experience is required, preferably with both small molecules and biologics
Strong knowledge of GMPs, ICH guidelines and Quality management systems
Experience with technology transfer to third parties
Experience with regulatory authority meetings and GMP site inspections
Extensive experience with analytical method development and validation
Expertise with stability testing, data trending and expiry setting strategy
Experience with testing injectable and oral dosage forms preferred
Experience in big pharma/biotech; experience in a startup biopharma company is desirable
Proficien.cy in MS Office, Word and Excel; statistical analysis software is desirable
Behavioral Competencies Required
Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with third party contract organizations
Excellent written and oral communication skills with a proven track record of developing employees
Self‑motivated and detail‑oriented, with the highest integrity
Other Responsibilities
Occasionally required to travel overnight
Ability to travel 10% of the time
Supervisory Responsibilities
Management and supervision of a small team and contractor(s)
Responsibilities may include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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