Director, Quality Control, CMC

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 include:
 

• 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.