GLP/GCLP Vendor Oversight and QA Lead (EU)
This role focuses on end-to-end quality oversight of external vendors and suppliers involved in regulated R&D activities, ensuring compliance with GLP, GCP, GMP, and GVP standards. The individual will lead vendor qualification, audit management, quality agreement negotiation, and continuous performance monitoring, while collaborating with cross-functional teams including Clinical, CMC, Safety, and Legal. A key aspect is driving compliance, data integrity (ALCOA+), and continuous improvement across third-party partners through risk-based assessments, CAPA follow-up, and QMS integration.