Cqa Vendor Oversight And Quality Assurance Lead (us)
CSL Behring
Not specified; not specified; benefits available p...
Fully remote
Glp gcp gmp gvp regulatory compliance
Vendor lifecycle management and oversight
Risk-based monitoring and qualification
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 through continuous improvement while ensuring adherence to global regulations.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives and operates one of the world's largest plasma collection networks.
Matching Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, CMOs, and laboratories.
Salary
Not specified; Not specified; Benefits available per CSL policy
Skills & Requirements
Must-have
GLP GCP GMP GVP regulatory compliance
Vendor lifecycle management and oversight
Risk-based monitoring and qualification
Quality agreement negotiation and maintenance
Inspection readiness and audit support
Data integrity ALCOA+ principles
CAPA implementation and verification
Nice-to-have
Cross-functional collaboration skills
Strong analytical problem solving abilities
Experience with multinational teams
Knowledge of ICH guidelines
Excellent communication and negotiation skills
Key Requirements
Bachelor's degree in relevant scientific discipline
3+ years of GxP quality experience
Direct vendor or CRO/CMO oversight experience
Demonstrated knowledge of FDA EMA and ICH regulations
Experience in audit and inspection management processes