This role owns the quality oversight of external partners supporting R&D and regulated activities to ensure adherence to GLP/GCP and data integrity standards
Job Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities to ensure adherence to GLP/GCP and data integrity standards.
The position requires leading the end-to-end vendor lifecycle including due diligence, qualification, risk-based monitoring, and issue management across CROs and laboratories.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture of inclusion and belonging that fuels innovation.
Matching Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities to ensure adherence to GLP/GCP and data integrity standards.
Skills & Requirements
Must-have
GLP/GCP regulatory compliance expertise
Vendor lifecycle management experience
GxP audit and inspection support
Risk-based monitoring strategies
Quality agreement negotiation skills
Nice-to-have
Strong cross-functional collaboration abilities
Data integrity ALCOA+ principles knowledge
Experience with multinational teams
Continuous improvement drive
Effective 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