CSL Behring is seeking a GLP Vendor Oversight and Quality Assurance Lead to oversee the quality management of external partners in research and development. The role involves managing the vendor lifecycle, ensuring compliance with regulations, and fostering collaboration across various departments
Job Summary
Own the quality oversight of external partners supporting R&D and regulated activities, leading the end-to-end vendor lifecycle.
Define and execute risk-based vendor qualification and requalification strategies, and contribute to drafting and negotiating Quality Agreements.
Stay current with GxP regulations and requirements, and provide guidance on third-party quality expectations and best practices.
Matching Summary
Match Score: 85
CSL Behring is seeking a GLP Vendor Oversight and Quality Assurance Lead to oversee the quality management of external partners in research and development. The role involves managing the vendor lifecycle, ensuring compliance with regulations, and fostering collaboration across various departments.
Skills & Requirements
Must-have
GLP/GCP vendor oversight
Risk-based vendor monitoring
Quality agreements negotiation
GxP audit support
Data integrity principles (ALCOA+)
Nice-to-have
Cross-functional collaboration
Continuous improvement initiatives
Regulatory trend analysis
Key Requirements
3+ years GxP quality experience
Vendor/CRO/CMO oversight/auditing
Knowledge of ICH, OECD GLP, FDA, EMA, EU Annex 11/21 CFR Part 11
Bachelor's degree in relevant scientific discipline