Associate Manager, Quality System, QA

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: Bachelors 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 detailoriented. Proficiency in quality risk management and linking risk outcomes to QMS impacts.
• Regulations & Standards: Deep knowledge for China GMPUS FDA 21 CFR EU GMP PIC/SICH Q9/Q10ATMP 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.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.