Qa Gcp SENior Manager

Qa Gcp SENior Manager focuses on implement and co-ordinate clinical qa activities to ensure compliance with gcp standards.

What the role involves

• Implement and co-ordinate clinical QA activities to ensure compliance with GCP standards.
• Ensure all clinical trial activities adhere to GCP regulations and internal procedures.
• Manage a risk-based audit programme, overseeing GCP audit activities internally, at vendors and at clinical sites.
• Provide oversight for clinical QA consultants and third-party organizations.
• Act as the Clinical QA Lead in preparation for regulatory inspections.
• Manage post-inspection follow-up.

Skills and requirements

• Senior Manager (title depending on experience) to oversee.
• Demonstrate strong expertise in Good Clinical Practice (GCP), with the strategic foresight and vision required to lead.
• Extensive GCP QA experience and a thorough understanding of Clinical Trial Applications (CTAs) and Investigational New Drug Applications (INDs).
• Manage time efficiently.

Confirmed role details

• Accession Therapeutics Limited, a clinical-stage company located on the ARC North Business Park in Oxford, is seeking a full-time QA GCP Associate Director.

Candidate fit

• BSc degree or equivalent qualification.
• At least 5 years’ experience in Quality Assurance, specifically GCP, within the pharmaceutical or biopharmaceutical industry.
• The position is primarily office-based, with some opportunity for remote work.