Lead the local implementation and operational excellence of AZ eQMS in China, covering document control, training, change control, deviation, and CAPA
Job Summary
Lead the local implementation and operational excellence of AZ eQMS in China, covering document control, training, change control, deviation, and CAPA.
Ensure quality systems are fit-for-purpose, compliant with applicable regulations (China GMP, US FDA, EU GMP, PIC/S, ICH), and support readiness for regulatory inspections and audits.
Develop and execute risk-based training programs to ensure personnel understand and comply with GMP requirements, AZ QCM, and cell therapy-specific quality practices.
Matching Summary
Lead the local implementation and operational excellence of AZ eQMS in China, covering document control, training, change control, deviation, and CAPA.
Skills & Requirements
Must-have
AZ eQMS implementation
GMP document control
Risk-based training programs
China GMP compliance
US FDA 21 CFR knowledge
EU GMP knowledge
ICH Q9/Q10 knowledge
Nice-to-have
Cross-functional collaboration
Continuous improvement drive
Strong ownership and self-motivation
Logical thinking and documentation skills
Key Requirements
Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
5+ years of experience in robust GMP quality system