Cqa Vendor Oversight And Quality Assurance Lead (us)
CSL Behring
Fully remote
Glp gcp gmp gvp regulatory compliance
Vendor lifecycle management and qualification
Risk-based monitoring and capa implementation
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 through risk-based monitoring and continuous improvement.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives using innovative therapies for immunology, hematology, and other therapeutic areas.
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 qualification
risk-based monitoring and CAPA implementation
GxP inspection and audit support
quality agreement negotiation and maintenance
Nice-to-have
strong cross-functional collaboration skills
experience with multinational teams
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 experience
Knowledge of ICH E6(R2), OECD GLP, FDA, EMA regulations
Understanding of data integrity principles (ALCOA+)