Lead Quality Systems and Compliance teams to ensure site-level Quality Systems are appropriately designed, implemented, and measured for cGMP compliance and effectiveness
Job Summary
Lead Quality Systems and Compliance teams to ensure site-level Quality Systems are appropriately designed, implemented, and measured for cGMP compliance and effectiveness.
Responsible for ensuring site compliance to health authority regulations and current good manufacturing practices, ensuring site inspection readiness and managing health authority inspections.
The company offers a wide variety of competitive benefits, services, and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives.
Matching Summary
Lead Quality Systems and Compliance teams to ensure site-level Quality Systems are appropriately designed, implemented, and measured for cGMP compliance and effectiveness.
Salary
$235,080 - $284,867
Skills & Requirements
Must-have
cGMP compliance and effectiveness
Health authority regulations
Site inspection readiness
Data Integrity program oversight
Quality Risk Management
Deviation, CAPA, Change Control
Nice-to-have
Cross-functional collaboration
Continuous improvement initiatives
High-performing team development
Innovative and resourceful approach
Key Requirements
12+ years experience in Cell Therapy, biotech or pharmaceutical
Extensive knowledge of Health Authority Regulations (FDA, EMA, PMDA)
Experience interfacing with health authorities and managing audits
Strong experience in Quality Management System structure and function
Bachelor’s degree within science discipline or related field