Major responsibilities

• Lead Local Implementation of AZ eQMS:

• Lead deployment and operational excellence of AZ eQMS in China for document control, training, change control, deviation, CAPA, etc.
• Act as the key liaison and point of contact between global project team and local process champions to ensure consistent system setup, process adherence, issue resolution, eQMS implementation.

• Lead local integration or implementation of AZ global quality management system applicable for cell therapy. Partnership with cell therapy US team for alignment of quality management requirements.
• Manage phase appropriate quality management system to ensure they are fit for different product phase (IIT, clinical phase I, phase II, phase III and commercial).

• Ensure quality systems are fit-for-purpose, compliant with applicable regulations and GMP, and support readiness for regulatory inspections and internal/external audits.

• Lead document management:

• Own local document management governance and ensure robust control of all GMP documents.
• Ensure full compliance of document creation, review, approval, issuance, revision, archiving, and obsoletion in line with established procedure and GRAD Schedule.

• Training to ensure they follow GMP requirements and AZ internal requirements:

• Develop and execute risk-based training programs to ensure all relevant personnel understand and comply with applicable regulations and GMP requirements, AZ QCM, cell therapy-specific quality practices, and quality management system processes.
• Monitor training effectiveness, maintain complete training records, and ensure staff are qualified prior to performing GMP activities.

• Maintain AZ ECMS and Cornerstone as local champion.

Education, Qualifications, Skills and Experience

• Education: Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field; Graduates from 985/211 universities or advanced degree are preferred.
• Experience: 5+ years of experience within a robust GMP quality system in pharmaceutical, with at least 2 years focused on Quality system. Experience within biologicals, MNC background is a plus.
• Technical Knowledge: Demonstrated QMS implementation/integration experience, organized and detail‑oriented. Proficiency in quality risk management and linking risk outcomes to QMS impacts.
• Regulations & Standards: Deep knowledge for China GMP, US FDA 21 CFR, EU GMP, PIC/S, ICH Q9/Q10, ATMP and data integrity related guidance. Ability to translate requirements into practical SOPs, workflows and training.
• Skills: Excellent communication and presentation skills, strong cross-function coordination capabilities, rigorous logical thinking, strong documentation aligned with ALCOA+.
• Language: Excellent English (spoken and written), able to communicate with global quality system team, and author high quality English documentation.
• Behavioral Attributes: Demonstrated strong ownership, self-motivation and execution. Excels at cross-functional collaboration and prioritization, drives continuous improvement.
• Experience with eQMS systems such as Veeva Enterprises Quality System.