Cqa Vendor Oversight And Quality Assurance Lead (us)
CSL Behring
Fully remote
Glp gcp gmp gvp regulatory compliance
Vendor lifecycle management and oversight
Risk-based monitoring and audit support
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, CMOs, and laboratories
Job Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, CMOs, and laboratories.
The position requires leading the end-to-end vendor lifecycle from due diligence and qualification to risk-based monitoring and continuous improvement.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology and hematology.
Matching Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, CMOs, and laboratories.
Skills & Requirements
Must-have
GLP GCP GMP GVP regulatory compliance
Vendor lifecycle management and oversight
Risk-based monitoring and audit support
Quality agreement negotiation and maintenance
Data integrity ALCOA+ principles
CAPA implementation and effectiveness checks
Nice-to-have
Cross-functional collaboration skills
Strong analytical problem solving abilities
Experience with multinational teams
Influence and negotiation expertise
Continuous improvement drive
Key Requirements
Bachelor's degree in relevant scientific discipline