GLP Vendor Oversight and Quality Assurance Lead
On-site · King of Prussia, Pennsylvania, United States
King of Prussia, Pennsylvania, United StatesOn-siteFull TimeMid LevelBachelors DegreeEnterprise
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Enterprise
Job Summary
Lead vendor oversight for GLP/GCP/GMP-compliant activities by managing the vendor lifecycle, risk-based qualification, quality agreements, and CAPA processes; drive inspection readiness, data integrity, and cross-functional collaboration with Nonclinical Development, Procurement, Legal, and IT; ensure adherence to regulations and continuous improvement across CROs/laboratories; support technology transfers, contract scoping, and training of internal stakeholders.
Required Qualifications
- Bachelor's degree in a relevant scientific discipline
- 3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing (GLP/GCP/GMP)
- Knowledge of OECD GLP, 21 CFR Part 58, Annex 11/Part 11 and data integrity (ALCOA+)
- Competencies: Works with limited supervision across multinational teams; strong analytical, problem-solving, communication, and organizational skills; experience in audit/inspection management and QMS implementation
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