Walker Cole International is searching for a QA Lead (Vendor Assurance) to join a Cell & Gene Therapy biotech in the South East of the UK. As the QA Lead (Vendor Assurance) you will support senior leadership with oversight of the wider QA team and the business’ QMS to ensure compliance and improvements.
Your responsibilities as the QA Lead (Vendor Assurance) will be:
*Establish processes for oversight of external suppliers and vendors whilst establishing processes for their qualification and approval
*Serve as the primary point of contact for both internal and external stakeholders on quality related matters
*Support in audit/inspection readiness programs and manage the External audit schedule
*Train, develop and mentor the QA team to promote a strong quality culture
The success candidate for the QA Lead (Vendor Assurance) position will demonstrate the following:
*Extensive experience in Quality Assurance within a GMP manufacturing environment for steriles, biologics or ATMPs
*A strong understanding of regulatory requirements and their application to Cell & Gene Therapy products
*An ability to demonstrate strong communication skills to maintain internal and external relationships
*Experience with GCP, GLP or GCLP regulations would be advantageous
ATMPs | Cell & Gene Therapy | Cell Therapy | Gene Therapy | Advanced Therapeutic Medicinal Products | QA | Quality Assurance | Quality Manager | Quality Director | QA Lead | GMP | Good Manufacturing Practice | GCP | GLP | Good Clinical Practice | Good Laboratory Practice