Senior Manager, R&D Quality Assurance

Senior Manager, R&D Quality AssuranceWe are seeking a Senior Manager, R&D Quality Assurance to serve as a QA Program Lead, providing oversight of Phase II/III clinical studies to ensure compliance with protocols, ICH-GCP, SOPs, and global regulatory requirements. The role is responsible for leading audit plans, inspection readiness activities (FDA, EMA, PMDA), managing CAPAs, and supporting vendor/process audits. The Senior Manager will partner with cross-functional teams to drive quality risk management, oversee compliance events, and ensure inspection readiness across studies. ***** Lead and execute study audit plans, Investigator Site Audits (ISAs), and CAPA management Drive inspection readiness for Health Authority inspections and support front-/back-room activities Provide QA oversight of clinical trials, ensuring adherence to protocol, SOPs, and ICH-GCP standards Manage compliance issues and quality events, guiding investigations and corrective actions Support vendor audits, process audits, and continuous quality improvement initiatives Collaborate with cross-functional teams and provide ad-hoc GCP quality guidance ***** Bachelor’s degree in life sciences; Master’s preferred 7+ years of GCP QA or related clinical research experience Experience leading audits, inspection readiness, and late-phase clinical trial oversight Strong knowledge of ICH-GCP and Health Authority regulations

Created: 2025-09-24