• 工作职责JOB RESPONSIBILITY
• Supervise and develop WuXi Biologics Warehouse On Line QA team to perform routine and non-routine records review, real time deviation handing & support any activities requiring QA oversight of GMP operations on the warehouse floor to ensure that appropriate SOPs and compliance standards are adhered.
• Support label management, product receiving and shipping, Inventory management, Equipment Qualification associated with Warehouse operation, Deviation and CAPA Management, Change Control system, Document Review and Approval related to warehouse functions In the system
• Ensure activities are managed in compliance with GMP expectations. Actively seek improvement of the systems to remain effective and relevant
• Supervise performance and development of direct reports to ensure achievement of WuXi Biologics goals.
• Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes. Manage and communicate compensation related information per company guidelines.
• Coach and develop staff by providing as environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receive appropriate knowledge and skill development and growth opportunities,
• Assign activities to staff. Routinely monitor progress and completion of assigned staff activities.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Assist QA Sr. Director in hosting regulatory or client inspections. Oversee the timely response and follow-up to any observations
• Be accountable for behaviors described in WuXi Biologics' Core, Common and Critical Competencies.
  

最低任职要求Minimum Requirement

教育程度/经验Education background/ Experience

• Bachelor of Science degree, scientific discipline preferred.
• Minimum 5-7 years of relevant experience in a regulated industry, pharmaceutical or medical device preferred.
• Minimum 5 years in Online QA functions.
• Minimum 3 years managerial or supervisory capacity.
• 特别知识Special knowledge
• Expert knowledge of Biopharmaceutical or Small Molecule Warehouse Operations operating under the control of Good Manufacturing Practices including NMPA, EMA, PIC/S and US-FDA requirement. 技能Skills
• Good level of English – reading, writing, speaking/comprehension & Native Mandarin.
• Excellent communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the organization and client base.
• Decision Making — Able to recognize important information necessary for solving problems. Able to identify when to escalate an issue. Objective in decision making/will consider alternative solutions. Able to make strategic and sound decisions on quality matters.
• Planning/Organizing — Identifies critical activities and assignments and adjusts priorities appropriately. Uses resources to complete tasks efficiently. Keeps effective control over tasks. Develop long-term plans.
• Teamwork — Works co-operatively, with a willingness to be part of a diverse team. Strives towards team's objectives. Keeps project leads and team members informed of the status of assigned work
• Advanced computer system and database skills – Excel, Word, Power Point, Outlook, etc.

上班地址：马山梅梁路108号

药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。截至2018年6月30日，在药明生物平台上研发的综合项目达187个，包括98个处于临床前研究阶段，78个在临床早期（I期，II期）阶段，10个在后期临床（III期）以及1个在商业化生产阶段。预计到2021年，公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能约22万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息，请访问：www.wuxibiologics.com.cn。
药明生物员工总数超过4000人，其中300多位是具有海外高等学位和工作经验的海归科学家，拥有欧美市场抗体开发、生产、质量控制、临床前研究和国际注册经验，高级管理层团队成员均工作在生物制药行业一线，并在各自专业领域平均拥有超过20年行业经验，打造了世界一流的生物药发现、开发及生产团队。