Cqa Vendor Oversight And Quality Assurance Lead (us)
CSL Behring
Fully remote
Glp gcp gmp gvp regulatory compliance
Cro cmo vendor lifecycle management
Risk-based monitoring and audits
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 for immunology and hematology conditions.
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
CRO CMO vendor lifecycle management
Risk-based monitoring and audits
Quality agreement negotiation
CAPA implementation and verification
Data integrity ALCOA+ principles
Nice-to-have
Cross-functional stakeholder collaboration
Continuous process improvement mindset
Strong analytical problem-solving skills
Experience with multinational teams
Effective communication and influencing
Key Requirements
Bachelor's degree in relevant scientific discipline