VP Quality Control

Life Sciences | Clinical Manufacturing | Advanced Cell Therapies

Are you ready to lead a Quality Control function that supports clinical manufacturing and prepares products for licensure?

Do you have the technical depth and leadership capability to build a high-performing QC laboratory in a regulated environment?

Are you confident acting as the Quality Control Subject Matter Expert in front of senior stakeholders and regulatory bodies?

Fraser Dove International is partnering exclusively with a pioneering biotechnology organisation developing advanced therapies. With a strong clinical pipeline and clear path towards commercialisation, they are investing in quality leadership to strengthen their control strategy and inspection readiness.

Our client is seeking a VP of Quality Control to lead internal QC operations and oversee Contract Testing Laboratories (CTLs), ensuring robust, compliant, and inspection-ready systems that support clinical supply and future licensure.

You will:

• Lead and develop the Quality Control laboratory, building structure, capability, and performance
• Oversee bioanalytical and compendial testing to support in-process, release, and stability programmes
• Act as QC Subject Matter Expert, supporting cross-functional teams and regulatory interactions
• Establish and maintain strong QC systems, including Out-of-Specification (OOS), deviations, Corrective and Preventive Actions (CAPAs), and change controls
• Partner with Research and Development (R&D) to transfer analytical methods into QC
• Coordinate closely with Manufacturing to support sample submission, testing schedules, and product release
• Drive inspection readiness and support regulatory inspections, including engagement with the United States Food and Drug Administration (FDA)

• 8 to 10+ years of biotechnology or pharmaceutical industry experience, including Quality Control in a current Good Manufacturing Practice (cGMP) setting
• 3+ years of people leadership experience, with a track record of building and developing high-performing teams
• Strong hands‑on expertise in assays such as western blot, flow cytometry, cell‑based assays, particle size analysis, Karl Fischer, and compendial methods
• Proven experience managing QC investigations, documentation, and quality systems in a regulated environment
• Experience supporting clinical manufacturing and product release
• Exposure to gene or cell therapy products is preferred
• Prior involvement in regulatory inspections is advantageous

This is a high‑impact leadership role offering the opportunity to shape QC strategy, strengthen compliance frameworks, and contribute directly to the advancement of innovative therapies.

If you are interested in exploring this opportunity, apply directly or contact Fraser Dove International for a confidential discussion.