The Vendor/Supplier QA Auditor 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 lifecycledue diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvementensuring 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
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 (roles/responsibilities, quality standards, change control, deviation management, data integrity, and inspection support).
Establish and assure upkeep of vendor KPIs/SLAs, quality dashboards, and governance forums for performance, risk, and remediation tracking.
Lead periodic vendor reviews (e.g., QBRs) as appropriate, ensuring KPIs achieve target level, actions, and corrective and preventive actions (CAPAs) are implemented/verified to assure the overa...