Cqa Vendor Oversight And Quality Assurance Lead (us)
cslbehring.de
Fully remote
Gxp quality experience with vendor oversight
Glp gcp gmp regulatory compliance knowledge
Risk-based vendor qualification strategies
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 and serves patients in more than 100 countries.
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
GxP quality experience with vendor oversight
GLP GCP GMP regulatory compliance knowledge
Risk-based vendor qualification strategies
Quality Agreement negotiation and management
Third-party audit and inspection support
Nice-to-have
Strong analytical and problem-solving 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