This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs and laboratories
Job Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs and laboratories.
The position requires leading the end-to-end vendor lifecycle from due diligence through qualification, risk-based monitoring, and continuous improvement.
Candidates must ensure adherence to GLP/GCP regulations, data integrity principles, and applicable international standards while partnering with cross-functional teams.
Matching Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs and laboratories.
Skills & Requirements
Must-have
GLP GCP regulatory compliance expertise
Vendor lifecycle management experience
Third party audit and inspection support
Risk assessment and CAPA implementation
Quality agreement negotiation skills
Nice-to-have
Cross functional collaboration abilities
Data integrity ALCOA plus knowledge
Multinational team leadership experience
Continuous improvement process drive
Key Requirements
Bachelor's degree in relevant scientific discipline
3+ years of GxP quality experience
Direct vendor/CRO/CMO oversight or auditing background
Knowledge of ICH E6(R2), OECD GLP, FDA, EMA regulations