M&S-China EM&S Quality Regulatory Manager-Shanghai

Job title 职位名称 : China EM&S Quality Regulatory Manager • Location工作地点： Shanghai 上海 About the job工作职责 We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities 职责描述： 职责描述Main Accountabilities 1. 建立并维护质量管理体系（B证）Establishment and maintenance of Quality Management System (B Certificate) • 负责建立并维护符合药品监管部门要求的委托生产质量管理体系，确保符合法规要求Being responsible for establishing and maintaining the contract manufacturing Quality Management System that comply with the regulatory requirements • 建立自检体系，监督相关质量管理体系的实施，并形成自检记录Establish the Self-Inspection system, monitor the implementation of relevant quality management system, and form self-inspection records • 负责质量风险沟通和回顾Responsible for quality risk communication and review • 负责质量管理评审，定义适当的质量指标，可视化合规表现，并推动持续改进Responsible for quality management reviews, defining appropriate quality metrics, visualizing compliance performance, and driving continuous improvement 2. 本地产品合规管理 Regulatory status Management of Local products • 与药监部门联络，跟进产品许可、GMP、招标证书和其他认证事宜Liaise with health authorities for follow ups on product permission, GMP, tender certificates and other certifications • 根据业务需求申请生产许可证、产品许可、及任何其他证书Applications for Manufacturing Licenses, Product Permissions & any other certificates as per the business requirements • 确保所有操作符合现行法律法规及内部政策，确保年度产品质量报告和年度药品报告的完成，并向监管部门提交必要的更新To ensure that all operations are in compliance with the current laws, regulations and internal policies, to ensure the completion of annual product quality report and annual drug report, and to submit necessary updates to the regulatory authorities • 协调监管机构检查，主持外部审计，并确保及时提交 CAPA 计划 Coordinate regulatory authority inspections, lead external audits, and ensure timely submission of CAPA plans 3.变更管理Change Control • 建立和维护变更控制系统，确保流程能够有效指导实施充分的变更风险评估并最大限度降低合规及产品质量风险Build and maintain change control system, to make sure effective procedures are in place to guide sufficient change risk assessment and minimize the risk of compliance and product quality • 确保与产品相关的上市后变更控制体系得到有效实施，并对受托产品的变更进行充分评估和风险管控Ensure the good implementation of the post-marketing change control system related to products, and effectively evaluation and risk control for the change of the entrusted product • 实施和关闭监管变更的 CAPA （纠正和预防措施） Implementation and closure of CAPA for regulatory change 4. 文件和培训管理 Documentation and Training • 维护监管数据库To maintain the regulatory database • 编制适用于本部门的SOP并维护相关记录Prepare SOPs applicable to the department and maintain relevant records • 建立和维护培训系统，包括培训矩阵维护，年度 GMP 培训等 Establish and maintain training system, including training matrix maintenance, annual GMP refresh training etc. 5. 包装材料设计稿审核 Artwork review • 根据监管要求审核和批准包装材料设计稿Review and approval of packing material artworks as per the regulatory requirements • 针对任何法规变更、新实施事项和设计稿改进，在跨职能团队之间进行有效沟通和协调 Effective communication and alignment between cross functional teams for any regulation change, new implementations, and improvisation of artworks 6. 供应商及物料管理Supplier and material management • 建立和维护供应商管理体系，包括供应商评估和批准，质量协议管理和供应商变更管理Supplier management system establishment and maintenance, including supplier evaluation and approval, quality agreement management and supplier change management • 支持对主要物料供应商的质量管理体系进行现场检查 Support to conduct on-site inspection of the QMS of major material suppliers 7. 合同生产监督Contract Production Supervision • 在委托生产期间实施驻厂，并对整个生产管理和质量管理过程进行现场指导和监督，确保生产工艺、质量标准等各方面均符合法规要求Perform person in plant (PiP) in the Contract Manufacturing Enterprise during the entrusted manufacturi