This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, laboratories, and technology vendors
Job Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, laboratories, and technology vendors.
The position requires leading the end-to-end vendor lifecycle from due diligence and qualification through continuous improvement and issue management.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, employing over 32,000 people across more than 100 countries.
Matching Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, laboratories, and technology vendors.
Skills & Requirements
Must-have
GLP/GCP regulatory compliance expertise
Vendor lifecycle management and qualification
Risk-based monitoring and CAPA implementation
GxP inspection and audit support experience
Data integrity principles ALCOA+
Quality agreement negotiation skills
Nice-to-have
Cross-functional collaboration with global teams
Strong analytical problem-solving abilities
Experience with ICH and OECD guidelines
Ability to work with limited supervision
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