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 continuous improvement to ensure adherence to GLP/GCP regulations.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives using innovative therapies across multiple therapeutic areas.
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 experience
Vendor lifecycle management and qualification
GxP audit and inspection support
Risk-based monitoring strategies
Quality agreement negotiation skills
Nice-to-have
Strong cross-functional collaboration abilities
Experience with multinational teams
Data integrity ALCOA+ principles knowledge
Continuous improvement drive
Excellent communication and influencing skills
Key Requirements
Bachelor's degree in relevant scientific discipline
3+ years of GxP quality experience
Direct vendor/CRO/CMO oversight or auditing background