• 招聘类型：社招
• 工作性质：全职

职位描述

1. Provide Quality guidance of cGMP external manufacturing operations (CMO)

2. Provide guidance and direction regarding manufacturing Quality to project teams

3. Act as Quality SPOC, lead Quality focused meetings between CMOs, partners, and BeiGene

4. Provide Quality support for batch disposition of drug substance, drug product and finished product

5. Drive, lead and quality investigations at CMOs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions

6. Provide Quality guidance and support for investigations and change controls

7. Provide support for process performance qualification activities including document review and approval

8. Advise on Quality Agreement content and support Quality Agreement implementation and updates

9. Ensure CMOs are compliance ready for regulatory inspections and monitor progress during inspections. Provide audit/inspection support of CMO as needed.

10. Monitor performance metrics and drive continuous improvements of CMO and BeiGene Shanghai as MAH

11. Maintain the Quality System of Beigene Shanghai as MAH

12. Lead the annual product reviews of products at BeiGene Shanghai as MAH

13. Co-Facilitate the Safety and Quality Joint Steering committee

任职条件

1. Bachelor degree or above

2. In-depth knowledge of GMPs especially Chinese GMP and EU/UP GMP requirements

3. In-depth knowledge of Quality principles, concepts, industry practices and standards

4. Excellent verbal, written and interpersonal communication skills

5. Ability to work independently with cross functional scientific/technical personnel

6. Knowledge of risk management tools a plus

7. Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日