• Provide guidance and direction regarding Quality Control and Assurance to project teams & CMO

• Lead and implement the batch record review including QC & MFG and support batch release work

• Support and implement the on-site quality control work in CMO per quality agreement and GMP

• Drive, lead and troubleshoot quality investigations /changes at CMOs to ensure that all critical and major quality control issues are thoroughly investigated with appropriate corrective actions

• Support annual product reviews and the development of training programs regarding all aspects of producing quality products

• Monitor performance metrics and drive continuous improvements of CMO QC work

• Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes

• Provide audit/inspection support of CMO, perform audits & support to regulation filling, as needed

职位要求：

• In-depth knowledge of Ch.P (NMPA), other regions including USP, EP and JP is preferred
• Familiar with lab operation including instrument, method, documentation, stability work in dteail
• Excellent verbal, written and interpersonal communication skills
• Ability to work independently with business/scientific/technical personnel is preferred
• Knowledge of risk management tools a plus

• Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to deta
• Interacts with all levels of BeiGene & CMO employees

• Interacts with members of China /SH NMPA

• Minimum of 5+ years pharmaceutical or biotechnology industry GMP experience in a quality control in manufacturing function

• Familiar with lab instruments including HPLC, GC, UV, IPC, ElISA, CZE etc

• Familiar with quality control work requirement of sterile product ( injectable solution)
  

上班地址：嘉里中心

地图

百济神州是一家全球性的生物制药公司，我们致力于成为具有创新性的分子靶向与免疫抗肿瘤药物研发领域领导者。

我们拥有1700+名员工和顾问组成的全球团队，其中包括超过200名科学家及临床医学专家。他们具有深入的科学知识、广泛的制药经验，并致力于为全球癌症患者提供有效安全的治疗药物。我们在全球多地设有办公地点和设施，包括位于美国旧金山、波士顿和新泽西的全球临床和商务总部，以及在澳大利亚、新西兰建立了临床开发分部。此外还在中国北京建立了研发中心，在中国苏州、广州设有生产基地。

2017年3月，百济神州与广州开发区合作，建设生物药生产基地，直接投资额达22亿人民币。广州生物药生产基地主要生产大分子单克隆抗体类抗癌药。基地采用全球领先的现代生产设备KUBio整体解决方案。

我们的目标是致力于成为一家在癌症研究、药物研发、人才培养和商业准则方面具有全球影响力的公司。

在这里，您的每一分努力都将得到肯定，您的个人价值将在公司的发展中得到充分的体现。