职责概要：



负责苏州及其他新建工厂的QA，QC以及验证部门，确保对NMPA，FDA GMP的合规性及持续性改进。



岗位职责：



在集团内建立合适的质量体系和程序以支持产品开发/上市全生命周期的安全性/有效性；

执行员工培训和发展项目，来保证公司整体运营；

负责权威机构审计以及跟踪；

保证IND/BLA申报资料的数据完整性；

对产品的质量事件提供技术指导以及帮助；

领导质量部门进行持续性改进工作；

负责QA部门相关活动，包括物料放行，产品放行，审计，偏差/CAPA管理，变更，内审以及文件控制；

负责QC部门相关活动，包括理化，生化以及微生物实验室；

监管分析方法验证以及方法转移活动；

负责验证相关活动，包括基于风险的设施，设备以及流程的验证。



任职资格：



大学硕士及以上学历，医药及相关专业毕业；

具有至少15年从事药品质量保证，质量控制或验证管理和实践经验，有生物药经验优先；

需要具备项目技术转移经验；

经历过工厂新建项目，具有良好的供应商协调管理能力；

良好的组织、协调、沟通、计划和执行能力；有责任心，能够承受挑战性工作的压力；

英语流利优先。







Position: Quality Head



Location: Suzhou



Job Summary:



Responsible for Quality Assurance, Quality Control and Validation Department in Suzhou and other site, ensure its regulatory compliance to FDA and NMPA cGMP and continuous improvement.



Responsibility：



Setup appropriate quality systems and procedures ensure product safety/efficacy and compliance with applicable regulations in the product lifecycle;

Implement the staff training and developing program to ensure overall development of organization;

Responsible for the regulatory agencies inspections and follow-ups;

Ensure that the data integrity correspond to the contents of IND/BLA submissions;

Provide technical leadership and assistance in quality matters of products;

Lead Quality Department in implementing continuous improvement activities;

Responsible for Quality Assurance activities including material releases, product releases, audits, Deviations/CAPAs Management, Change Control, internal audit and documentation control;

Responsible for Quality Control activities including Physical Chemistry, Biochemistry and Microbiology Laboratories;

Oversight for analytical method validation and method transfer activities;

Responsible for Validation activities to ensure a risk-based lifecycle approach to validation practices regarding facility, equipment and process.



Qualification:



Master’s degree or above, medicine or related major;

15 years or above QA/QC/validation working experience, biologics experience is preferable;

Familiar with new project tech transfer process;

Experienced the new facility project and external supplier management;

Good organization, coordination, communication, planning and execution ability; Responsible and able to work under pressure.

Fluent English is a plus.