具体要求

岗位名称3：著名制药企业质量管理高级副总裁

岗位职责：

1、Responsible for managing entire quality team and organizing GMP quality activities.

负责管理整个质量团队，组织 GMP 质量活动；

2、Coordinate QA and QC operations in accordance with GMP related procedures. Ensure that all products are manufactured in accordance with GMP requirements.

根据 GMP 相关程序协调 QA 和 QC 操作。确保所有产品都符合 GMP 要求；

3、Ensure that raw material, packing material, intermediates, bulk product and final product have satisfied approval requirements and quality standards.

确保原材料、包装材料、中间产品、散装产品和最终产品符合认可要求和质量标准；

4、Approve operating procedure of quality standards, sampling methods, test methods and other quality management operations.

批准质量标准、抽样方法、试验方法和其他质量管理操作程序；

5、Ensure that QC and QA personnel have all been trained and kept up to date.

确保 QC 和 QA 人员都接受培训并不断更新；

6、Ensure that all complaints related to product quality have been investigated and treated appropriately on time.

确保所有与产品质量有关的投诉都得到了及时的调查和处理；

7、Ensure completion review analysis of product quality.

确保产品质量的完成评审分析。

任职要求：

1、Advanced degree in a relevant scientific discipline (i.e. chemistry, biology, chemical or pharmaceutical engineering).

具有相关科学学科的硕士学位（如化学、生物、化学或制药工程）；

2、More than 10-years’ experience in biologics quality management.

10 年以上生物制品质量管理经验；

3、Experience in managing a large group of employees.

有管理大量员工的经验。

4、Hands on GMP experience with all phases of drug development and manufacturing, as well as in-depth knowledge and full understanding of GMP requirements.

熟悉药品开发和制造的各个阶段的 GMP 经验，深入和全面了解 GMP 要求。

5、Strong leadership and excellent verbal & written communication skills.

优秀的领导能力和优秀的口头和书面沟通能力。

6、Well-versed in technical and GMP knowledge to support Regulatory, Quality, Validation Compliance, Research & Development, and Manufacturing requirements for regulatory agency approval

熟悉技术和 GMP 知识，以支持法规、质量、验证、合规、研究和开发以及管理机 构批准的制造要求；

7、Fluent in English and Chinese.

中英文流利。

工作地点：山东省烟台市

请将个人简历投递至：Resume.shandong@fesco.com.cn

薪资福利待遇：面议