QA GCP Senior Manager/ QA GCP Associate Director

QA GCP SENIOR MANAGER / QA GCP ASSOCIATE DIRECTOR

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 / Senior Manager (title depending on experience) to oversee and manage Clinical Quality Assurance activities.

The successful candidate will demonstrate strong expertise in Good Clinical Practice (GCP), with the strategic foresight and vision required to lead and develop the Quality Assurance department, especially as the company navigates a changing industry landscape.

Key Responsibilities

• 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;
• Develop and manage a risk-based audit programme, overseeing GCP audit activities internally, at vendors and at clinical sites;
• Supervise and provide oversight for clinical QA consultants and third-party organizations;
• Act as the Clinical QA Lead in preparation for regulatory inspections and manage post-inspection follow-up;
• Monitor and track Key Performance Indicators (KPIs) for the reporting of Quality Metrics;
• Undertake additional assignments, as directed by the Head of Quality and Strategy.

Essential Qualifications and Skills

• Extensive GCP QA experience and a thorough understanding of Clinical Trial Applications (CTAs) and Investigational New Drug Applications (INDs)
• Expert knowledge of applicable regulations
• Proven ability to meet deadlines and manage time efficientlyStrong communication skills
• Ability to collaborate effectively within cross-functional project teams
• Exceptional attention to detail

Person Specification

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; occasional travel will also be required.

Accession offers a good salary and company benefits including pension, private health insurance, life insurance and subsidized local gym membership.

Accession Therapeutics Limited is an Equal Opportunities employer

#J-18808-Ljbffr