Typical Accountabilities

主要职责

Specific Responsibilities/Tasks

具体职责/任务

Quality Assurance Management 质量保证管理

Ensure all activities in the new factory comply with GMP requirements and regulatory standards.确保新工厂的所有活动符合GMP要求和法规标准。Accountable for all quality decision-making of the project and works directly with client tam director to deliver project objectives, across all the stages of the project from design to the 1st product supply from PP and CDC line, incl. quality documents reviewing/signing, deviation handling, C&Q witness, knowledge transfer of CDC and PP technology, CMC study for the 1st product introduction in the PP and CDC line, etc.负责项目的质量决定，直接与用户团队总监负责人共同工作支持项目目标实现, 从设计到PP和CDC生产线首批产品供应的所有阶段进行评估、判断和决策，包括质量文件审阅/签署、偏差处理、C&Q见证、CDC和PP技术知识转移、PP和CDC生产线首批产品引进的CMC研究等。Lead, facilitate and support key business processes on behalf of QA in new factory.代表QA领导、推进和支持新工厂业务流程Ensure all processes and procedures are appropriately documented and that relevant quality metrics are tracked and managed.确保所有流程和程序得到适当的记录，并管理相关的质量指标。

Project Management 项目管理

Serve as the primary contact for all quality matters related to the project.作为项目所有质量事务的主要联络人。Conduct communications across Wuxi site quality leadership team to share the progress of the new project execution.与无锡工厂质量管理团队进行沟通，分享新项目实施的进展情况。Lead the establishment and implementation of quality management system for the new factory.领导新工厂质量管理体系的建立和实施。Support quality Sr. director to build quality resource model and organization structure for new factory.协助质量高级总监建立新工厂质量的资源模式和组织架构。

Stakeholder Focus 利益相关方

Establishing and engaging internal and external stakeholders 与全球和本地的利益相关方或者项目组保持良好的业务关系

Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力

Education, Qualification, Experience 教育、资质、经验

Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry.大学本科以上学历，执业药师，药学或相关专业毕业Has solid experience in GMP environment of pharmaceutical industry制药行业丰富GMP工作经历5+ years prior experience in GMP manufacturing，  quality system management, project management。5年以上的从事药品生产、质量体系管理、项目管理经验的实践经验

Capabilities能力

Advanced knowledge of cGMP requirement, quality management system and pharmaceutical manufacturing manufacturing technologies 具有全面的GMP，质量管理体系和药品生产知识Advanced knowledge of up-to-date technology and regulatory trend对行业技术和法规具有与时俱进的认识Proven leadership capability and ability to manage projects. 具有卓越的领导能力和项目管理能力。Good collaboration, team coaching and people development capability良好的合作、团队建设和人员发展能力Demonstrated judgment and influence ability make decisions to ensure patient safety and to protect company reputation.判断力和影响力，能够做出决定确保病患的安全和保护公司的声誉Good command of English良好的英文能力

Date Posted

22-Apr-2025

Closing Date

30-Dec-2025

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.