教育程度/经验Education background/ Experience 大学本科及以上学历，药学、生物细胞学、生物化学或相关专业毕业；高级学位，有商业化生产的CMO经验是加分项 At least Bachelor degree, major in pharmaceutical, cell biology, biochemistry or related subjects. Advanced degree and CMO working experience are plus. 特殊要求： 符合中国商业化GMP的质量负责人和质量受权人的要求； 英语听、说、读、写流利 工作职责 Responsibilities 以GMP为标准，建立健全药明生物成都工厂商业化质量管理体系，保证体系有效运行； Establish and improve WuXi Biologics quality management system at Chengdu site, ensure the system work effectively 根据公司战略目标，制订公司的年度质量方针目标，并组织实施； Build CMAB annual quality policy goals according to the company’s strategic goals, and organize the implementation 负责质量部门的组织建设、高效的人员绩效管理工作。 Responsible for the construction and efficient personnel performance management of quality department 领导质量部的战略发展，使之成为不断追求卓越和发展的重要部分 Lead strategic development of quality department and make it an important part of the continuous pursuit of excellence and development 领导质量部建立质量和法规的***方案，使之符合法规的要求和客户的期望、并能给业务带来有竞争力的有利条件 Lead quality department function to build best practices for quality /compliance that meet regulatory requirement, customer expectation and deliver competitive advantage to business 实施人才培养战略，促进全面的发展和组织的领导力 Implement talent development strategy to drive overall development of organization leadership 领导并激励团队达到设定的目标和KPIs Lead and motivate teams to achieve established goals and KPIs 招聘、选择、培训及评估直接汇报人员 Recruit, select, train, appraise performance for reporting employees 致力于运行成本最优化、进行改善方案、成本控制活动，提高工作效率 Optimize the running economy, initiate improvements, cost-saving activities and increase working efficiency 负责工厂的法规符合性 Responsible for maintaining of compliance with regulatory requirements for chengdu site 负责公司质量体系的建立和维护 Responsible for establishment and maintenance of quality system 负责质量团队的日常管理 Responsible for routine management of quality team 确保原辅料、包装材料、中间品、待包装产品和成品符合经注册批准的要求和质量标准 To ensure that the raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products meet the requirements and quality standards approved by the registration 负责内、外部审计 Responsible for internal/ external audit for each site 确保完成自检 Ensure implementation of self-inspection 监督厂房和设备的维护，以保持其良好的运行状态 Check the maintenance of his department, premises and equipment 确保完成各种必要的验证/确认工作，审核和批准确认或验证方案和报告 Ensure that the appropriate validations/qualification are done 确保本部门及企业所有相关人员都已经过必要的上岗前培训和继续培训，并根据实际需要调整培训安排 Ensure that the required initial and continuing training of quality department personnel is carried out and adapted accordingly 审核和批准产品的质量标准， 主批记录等文件 Review and approve product specification, master batch records, etc. 评估和批准物料供应商, 批准并监督委托生产， 委托检验 Approve and monitor materials suppliers, contract manufacturers, and contract labs 批准质量标准、取样方法、检验方法和其他质量管理的操作规程 To approve quality standards, sampling methods, inspection methods and other quality management operating procedures. 负责风险的管理 Responsible for the risk management GMP执行状况的监控 Responsible for the monitoring of compliance with the requirements of Good Manufacturing Practice 审核和批准与质量有关的变更 Assess and approve quality related changes 确保所有重大偏差和超标结果经过调查并及时处理 Ensure the deep investigation and handling of deviation and OOS 确保所有与产品质量有关的投诉已经过调查，并得到及时、正确的处理 Ensure the deep investigation and handling of quality related compliant 审核/批准稳定性试验方案/报告 Review and approve stability test protocols/reports 负责产品召回 In charge of product recall 确保完成产品的持续稳定性考察计划，提供稳定性考察的数据 To ensure the completion of the continuous stability inspection plan of the product, and provide the data for the stability inspection 确保完成产品质量回顾分析 To ensure the completion of product quality review and analys*******************