CQA Vendor Oversight and Quality Assurance Lead (US)

Job description

The CQA Vendor Oversight and Quality Assurance Lead role will own the quality oversight of external partners supporting R&D and regulated activities (e.g., CROs, CMOs, laboratories, technology vendors). Lead the end-to-end vendor lifecycle—due diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvement—ensuring adherence to GLP/GCP/GMP/GVP, data integrity and applicable regulations. This role partners closely with Clinical, Nonclinical, CMC, Safety, Procurement, Legal, and IT to enable compliant, reliable delivery from third parties. Main Responsibilities and Accountabilities: 1. Vendor Lifecycle & Governance 2. Inspections 3. Quality Systems & Compliance 4. Risk Management & Continuous Improvement 5. Cross Functional Partnership 6. Maintain and share knowledge of Regulations and Requirements - Define and execute risk-based vendor qualification and requalification strategies (paper assessments, remote/onsite diligence assessments, performance reviews). - In collaboration with R&D/Technical/Legal and QA Functional teams contribute to drafting, negotiating, and maintain Quality Agreements aligned to master service agreements (role...