The role involves leading the deployment and operational excellence of the AZ eQMS specifically for document control, training, and change control within China
Job Summary
The role involves leading the deployment and operational excellence of the AZ eQMS specifically for document control, training, and change control within China.
Candidates must ensure quality systems are fit-for-purpose across all product phases from IIT to commercial while maintaining compliance with global and local regulations.
The position requires acting as a key liaison between the global project team and local process champions to drive consistent system setup and issue resolution.
Matching Summary
The role involves leading the deployment and operational excellence of the AZ eQMS specifically for document control, training, and change control within China.
Skills & Requirements
Must-have
5+ years GMP quality system experience
China GMP and US FDA 21 CFR knowledge
eQMS implementation and integration expertise
Cell therapy quality management requirements
Risk-based training program development
Nice-to-have
MNC background in biologicals
Experience with Veeva Enterprises Quality System
Strong cross-functional collaboration skills
Advanced degree from 985/211 university
Deep knowledge of ATMP regulations
Key Requirements
Bachelor's degree in pharmacy or Life Sciences
Minimum 5 years experience in robust GMP quality system