GLP/GCLP Vendor Oversight and QA Lead (EU)
Core
Lead quality oversight and governance for external partners (CROs, labs) supporting nonclinical GLP research to ensure data integrity and regulatory compliance.
Role type
Senior Quality Lead (Vendor Oversight & QA)
Builds
Robust vendor quality management systems and compliant nonclinical research networks
Domain
Life Sciences / Nonclinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
GLP/GCP/GMP regulatory knowledge, vendor lifecycle management, risk assessment, audit planning and execution, data integrity (ALCOA+), quality agreement drafting, stakeholder negotiation
Preferred skills
Experience with OECD GLP, 21 CFR Part 58, Annex 11/Part 11, QMS implementation
Technologies
QMS platforms, risk management tools
Responsibilities
Run risk-based vendor qualification and requalification; plan and conduct vendor audits; ensure vendor adherence to GLP/GxP and data integrity standards; lead vendor risk assessments and performance monitoring; translate regulatory changes into internal requirements
Seniority
Senior, hands-on IC with limited supervision