CSL Behring is seeking a GLP Vendor Oversight and Quality Assurance Lead to oversee quality compliance for external partners in R&D and regulated activities. The role involves managing vendor relationships, ensuring adherence to GxP standards, and collaborating with various internal departments
Job Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities ensuring adherence to GLP/GCP regulations.
The position requires leading the end-to-end vendor lifecycle including due diligence, qualification, risk-based monitoring, and issue management.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies for patients.
Matching Summary
Match Score: 85
CSL Behring is seeking a GLP Vendor Oversight and Quality Assurance Lead to oversee quality compliance for external partners in R&D and regulated activities. The role involves managing vendor relationships, ensuring adherence to GxP standards, and collaborating with various internal departments.
Skills & Requirements
Must-have
GLP GCP regulatory compliance expertise
Third party vendor lifecycle management
Risk based monitoring and auditing
Quality agreement negotiation skills
CAPA implementation and verification
Data integrity ALCOA principles
Nice-to-have
Cross functional stakeholder collaboration
Strong analytical problem solving abilities
Experience with multinational teams
Effective communication and influencing skills
Continuous improvement process drive
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 FDA EMA regulations
Experience with audit inspection management processes