CSL Seqirus is seeking a GLP Vendor Oversight and Quality Assurance Lead to oversee the quality management of external partners in R&D and regulated activities. The role involves managing vendor lifecycles, ensuring compliance with GLP/GCP standards, and fostering cross-functional partnerships to enhance vendor performance and risk management
Job Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, laboratories, and technology vendors.
The position requires leading the end-to-end vendor lifecycle from due diligence and qualification to risk-based monitoring and continuous improvement.
CSL Seqirus is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other therapeutic areas.
Matching Summary
Match Score: 85
CSL Seqirus is seeking a GLP Vendor Oversight and Quality Assurance Lead to oversee the quality management of external partners in R&D and regulated activities. The role involves managing vendor lifecycles, ensuring compliance with GLP/GCP standards, and fostering cross-functional partnerships to enhance vendor performance and risk management.
Skills & Requirements
Must-have
GLP/GCP regulatory compliance expertise
Vendor lifecycle management experience
Third-party audit and inspection support
Risk-based monitoring strategies
Quality agreement negotiation skills
Data integrity ALCOA+ principles
Nice-to-have
Cross-functional stakeholder collaboration
Continuous improvement process drive
Multinational team leadership
Strong analytical problem solving
Effective communication and influencing
Key Requirements
Bachelor's degree in relevant scientific discipline
3+ years of GxP quality experience
Direct vendor/CRO/CMO oversight or auditing background
Knowledge of ICH, OECD GLP, FDA, EMA regulations
Experience with data integrity and QMS implementation