Director of Quality Control

Role Summary

The Director, Quality Control provides strategic leadership for QC activities, defines QC strategy, and leads a growing team of QC scientists. This role oversees QC-related operations across all phases of product development (clinical and commercial) for large- and small-molecule products, ensuring compliance with cGMP and regulatory requirements.

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, statistical 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 CMC 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
• Supervise and develop QC staff and contractors, including interviewing, hiring and training, assigning work, and evaluating performance

Qualifications

• Required: 10+ years Quality Control experience
• Preferred: preferably with both biologics and small molecules
• Required: Strong knowledge of GMPs, ICH guidelines and Quality management systems
• Required: Experience with analytical methods technology transfer to third parties
• Required: Experience with regulatory authority meetings and GMP site inspections
• Required: Extensive experience with analytical method development and validation
• Required: Expertise with stability testing, data trending and expiry setting strategy
• Preferred: Experience with testing injectable and oral dosage forms
• Preferred: Experience in big pharma/biotech; startup biopharma company desirable
• Preferred: Proficiency in MS Office, Word and Excel; statistical analysis software desirable

Education

• PhD in Analytical Chemistry, Biochemistry, Biology or a related scientific field

Skills

• 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

Additional Requirements

• Travel up to 10% of the time