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 manufacturing of drugs and carry out on-site guidance and supervision over the whole process of production management and quality management to ensure that the production process, quality standards etc. comply with regulatory requirements
- 季度评估受托方（CMO）的质量管理体系，确保其持续符合合同规定的标准，并履行质量保证协议（QAA）中的各项义务，保证双方质量管理体系的有效衔接Quarterly evaluate QMS of the entrusted party (CMO) to cnsure it continues to meet the standards stipulated in the contract and fulfil the obligations stipulated in the Quality Assurance Agreement (QAA) to ensure effective integration of QMS of both parties
8.其他活动Other activities
- 与跨职能团队协调，准备向药监部门提交注册申报资料或其他申请所需的监管文件。积极参加利益相关方组织的会议Co-ordination with cross functional teams for regulatory documents required for submission of dossier or other applications to health authorities. Actively participate in the meeting organized by stakeholders
- 审核影响EM & S中国区产品组合的药典变更，并制定变更实施行动计划Review of Pharmacopoeia changes impacting to EM & S China product portfolio and make action plan for Implementation of the change
- 必要时，作为质量负责人（质量授权人）的转授权者做出质量决定Make quality decisions as a delegate to the quality responsible person (QP) when necessary
- 完成经理分配的其他任务Any other assignment allocated by manager
About you 任职资格:
List here ideally the must-haves criteria to be successful on the role.
请列出胜任该职位所必须具备的条件。
- 药学、化学、生物学、生物化学或相关专业硕士及以上学历Master and above of Pharmacy, Chemistry, Biology, Biochemistry or relevant majors
- 具有至少5年从事药品生产和质量管理的实践经验，其中至少3年无菌药品生产和质量管理的实践经验。有MAH制度运作经验者优先Must have at least 5 years of practical experience in pharmaceutical production and quality management, including at least 3 years of practical experience in sterile drug production and quality management. Experience with MAH (Marketing Authorization Holder) system operations is preferred.
- 熟悉NMPA和EMA等GMP法规，熟悉ICH指南及相关要求，了解MAH制度相关规定，具备生物制品质量与生产管理、质量控制及产品生产流程等方面的专业知识Familiar with GMP regulations such as NMPA and EMA, familiar with ICH guidelines and requirements, familiar with relevant provisions of MAH system, and professional knowledge in the quality and production management of biological products, quality control and product production processes.
- 具备良好的检查管理能力、分析与问题解决能力Good inspection management, analysis solving problems abilities
- 对行业最新技术和法规有持续的了解Up-to-date understanding of industry technologies and regulations
- 具备足够的判断力和影响力，能够做出决策以保障患者安全并维护公司声誉Sufficient judgment and influence to make decisions to ensure patient safety and protect the company's reputation
- 具备出色的沟通与协调能力，能够高效开展跨部门、跨企业的工作Excellent communication and coordination to work efficiently across functional, cross-enterprise.
- 具备较强的责任心、执行力和抗压能力Strong responsibility, execution and resilience
- 具备良好的英语能力Good English skills
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Pursue Progress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!