Senior Manager, R&D Quality Assurance (GCP)

Senior Manager, R&D Quality Assurance (GCP)

Proclinical is seeking a Senior Manager, R&D Quality Assurance (GCP) to provide clinical quality oversight for assigned clinical studies. In this role, you will ensure compliance with protocols, international and local regulations, and Good Clinical Practice (GCP) standards. You will lead inspection readiness efforts, support audit activities, and contribute to quality assurance initiatives. The position offers a hybrid working model based in Maidenhead, UK.

Responsibilities:

• Act as the QA Program Lead, overseeing compliance with protocols, company SOPs, GCP, and regulatory guidance.
• Develop and execute study audit plans, including investigator site audits, audit reports, and corrective/preventive action plans.
• Lead quality activities for late-phase clinical trials, focusing on risk management and endpoint de-risking.
• Address compliance issues, including sponsor, clinica...