JobMesh

GLP Vendor Oversight and Quality Assurance Lead

CSL · King Of Prussia, Pennsylvania, US

The Opportunity: - The GLP Vendor Oversight and Quality Assurance Lead role will own the quality oversight of external partners supporting R&D and regulated...

Job description

The Opportunity: The GLP Vendor Oversight and Quality Assurance Lead role will own the quality oversight of external partners supporting R&D and regulated activities (e.g., CROs, 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, data integrity and applicable regulations. This role partners closely with Research, Clinical, Nonclinical, 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...