The role involves leading the deployment and operational excellence of the AZ eQMS in China for various quality processes including document control and CAPA
Job Summary
The role involves leading the deployment and operational excellence of the AZ eQMS in China for various quality processes including document control and CAPA.
Candidates must ensure quality systems are fit-for-purpose, compliant with regulations like China GMP and US FDA 21 CFR, and ready for regulatory inspections.
The position requires managing phase-appropriate quality management systems for cell therapy products ranging from IIT to commercial phases.
Matching Summary
The role involves leading the deployment and operational excellence of the AZ eQMS in China for various quality processes including document control and CAPA.
Skills & Requirements
Must-have
5+ years GMP quality system experience
2+ years focused on Quality system
Deep knowledge China GMP US FDA EU GMP
Proficiency in quality risk management
Experience with Veeva Enterprises Quality System
Nice-to-have
Biologicals industry background preferred
MNC background is a plus
Graduates from 985/211 universities preferred
Strong cross-functional collaboration skills
Excellent English communication abilities
Key Requirements
Bachelor's degree in pharmacy or Life Sciences
5+ years experience in robust GMP quality system
2+ years focused specifically on Quality system
Advanced degree or 985/211 university graduate preferred