Typical Accountabilities:

• Maintain the QMS of China MCOQ to ensure the compliance to AstraZeneca QCM &standards and GSP regulations regarding to China trading companies.

• Serve as quality liaison to the drug regulatory agency (if required), support GMP&GDP audits and inspections, and support the smooth closure of inspections.

• To maintain / improve efficient product batch evaluation procedure to ensure the product supply is maintained at a high-quality standard.

• Responsible for China MCOQ Wholesaler Quality Life Cycle Management.

• Responsible for China MCOQ product/ Wholesaler/ service suppliers Quality Assurance Agreement (QAA) Quality Life Cycle Management.

• Responsible for the quality events handling during the daily business, including but not limited to deviation, complaint, etc.

• Lead, facilitate and support key business processes on behalf of QA in supply chain.

• To be part of global vendor program management, support imported finished products management and work with sending site QA, EQ and global cooperate quality.

• Responsible for the achievement of quality KPIs and objectives/Quality Plans. Ensure adverse trends related to quality compliance are addressed through development of continuous improvement plans.

• Support QMS compliance and continuous improvement in China MCOQ , actively identify issues, concerns, and risks and escalate timely.

• Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally.

• Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in AstraZeneca’s Quality related needs.

• Drive the quality process improvement and simplification as quality business process champion, ensuring GMP/GDP/GSP compliance and AZ global standard compliance.

• Identify and understand the SHE risk factors within the department.

Requirements：

• Chemistry, Digitalization.  Licensed pharmacist is preferred.

• 10+ years prior experience in GMP/GSP/GDP and compliance management environment.

• 5+ years’ experience of supplier quality management or distribution quality management.

• Experience of working cross functionally across the supply chain with groups such as regulatory affairs, manufacturing, supply, and account management, etc.

• Overall quality management system and GMP/GSP/GDP knowledge.

• Expert of GMP/GSP and market company quality systems.

• Experienced in Digitalization

• Expert of quality management system key process and quality risk management.

• Wide network in the industry and local authority.

• Good collaboration, team coaching and people development capability.

• Good command of English.

• Good Computer skill.

• Good communication skills, proactive leadership, strong quality, and service minds.