Cqa Vendor Oversight And Quality Assurance Lead (us)
CSL SEQIRUS
Fully remote
Gxp quality experience with vendor oversight
Risk-based vendor qualification strategies
Glp/gcp/gmp regulatory compliance knowledge
This role owns the end-to-end quality oversight of external partners supporting R&D and regulated activities including CROs, CMOs, and laboratories
Job Summary
This role owns the end-to-end quality oversight of external partners supporting R&D and regulated activities including CROs, CMOs, and laboratories.
The position requires leading risk-based vendor lifecycle management from due diligence through continuous improvement while ensuring adherence to GLP, GCP, GMP, and GVP regulations.
CSL Seqirus offers a global biotherapeutics environment focused on saving lives through innovative therapies for immunology, hematology, and other critical therapeutic areas.
Matching Summary
This role owns the end-to-end quality oversight of external partners supporting R&D and regulated activities including CROs, CMOs, and laboratories.
Skills & Requirements
Must-have
GxP quality experience with vendor oversight
Risk-based vendor qualification strategies
GLP/GCP/GMP regulatory compliance knowledge
Data integrity ALCOA+ principles
Audit and inspection management skills
Nice-to-have
Strong negotiation and influencing skills
Experience with multinational teams
Ability to work with limited supervision
Cross-functional partnership capabilities
Continuous improvement drive
Key Requirements
Bachelor's degree in relevant scientific discipline