Cqa Vendor Oversight And Quality Assurance Lead (us)
CSL Behring
Fully remote
Glp/gcp/gmp/gvp adherence
Vendor lifecycle management
Risk-based vendor monitoring
Lead the end-to-end vendor lifecycle—due diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvement—ensuring adherence to GLP/GCP/GMP/GVP, data integrity and applicable regulations
Job Summary
Lead the end-to-end vendor lifecycle—due diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvement—ensuring adherence to GLP/GCP/GMP/GVP, data integrity and applicable regulations.
Support planning of routine GxP audits of CROs, CMOs, labs, and system/service providers; ensuring findings are classified, graded, and reported internally and externally.
Collaborate with Clinical Operations, Nonclinical, CMC, Safety, Supply Chain, Procurement, Legal, and IT to embed quality requirements in scopes of work and contracts.
Matching Summary
Lead the end-to-end vendor lifecycle—due diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvement—ensuring adherence to GLP/GCP/GMP/GVP, data integrity and applicable regulations.
Skills & Requirements
Must-have
GLP/GCP/GMP/GVP adherence
Vendor lifecycle management
Risk-based vendor monitoring
Quality agreements negotiation
GxP audit planning and support
Nice-to-have
Cross-functional collaboration
Continuous improvement initiatives
Data integrity principles (ALCOA+)
Key Requirements
3+ years of GxP quality experience
Direct vendor/CRO/CMO oversight and/or auditing
Knowledge of ICH, OECD GLP, FDA, EMA, EU Annex 11/21 CFR Part 11
Bachelor’s degree in relevant scientific discipline