• 招聘类型：社招
• 工作性质：全职

职位描述

• Provide guidance and direction regarding packaging site manufacturing operations to Quality to project teams
• Lead Quality focused meetings between CMOs, partners, and BeiGene
• Provide Quality support for batch disposition of packaged and labeled products
• Drive, lead and troubleshoot quality investigations at CMOs and logistics providers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions
• Provide Quality guidance and support for investigations and change controls
• Provide support for process performance qualification activities including document review and approval
• Advise on Quality Agreement content and support Quality Agreement implementation and updates
• Ensure CMOs are compliance ready for regulatory inspections and monitor progress during inspections. Provide audit/inspection support of CMO as needed.
• Perform audits, as needed
• Monitor performance metrics and drive continuous improvements of CMO and internal processes
• Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes
• Support regulatory filings, as needed
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products

任职条件

• Bachelor of Science degree, in a related scientific discipline
• Minimum of 10 years pharmaceutical or biotechnology industry GMP experience in a quality and manufacturing function
• Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail
• Interacts with all levels of BeiGene employees including CMOs
• In-depth knowledge of GMPs (EU, US, CN, AU, JP)
• In-depth knowledge of Quality principles, concepts, industry practices and standards
• Excellent verbal, written and interpersonal communication skills
• Ability to work independently with scientific/technical personnel
• Knowledge of risk management tools a plus

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