GLP/GCLP Vendor Oversight and QA Lead (EU)
Core
Lead quality oversight of external partners (CROs, laboratories) supporting nonclinical and GLP activities to ensure data integrity and regulatory compliance.
Role type
Senior Quality Lead (Vendor Oversight & QA)
Builds
Quality oversight framework for external nonclinical research network
Domain
Life Sciences / Vaccines / Nonclinical Research / Regulatory Compliance
Required skills
GLP/GCP/GMP regulatory knowledge, vendor lifecycle management, risk assessment, audit planning, data integrity (ALCOA+), quality agreement drafting, stakeholder negotiation
Preferred skills
OECD GLP, 21 CFR Part 58, Annex 11/Part 11, QMS implementation, change control management
Technologies
QMS systems, risk registers, FMEA tools
Responsibilities
Run risk-based vendor qualification and requalification; plan and coordinate vendor audits; ensure vendor compliance with GLP/GxP and data integrity standards; lead vendor risk assessments and performance monitoring; translate regulatory changes into internal requirements
Seniority
Senior, hands-on IC
