Job title职位名称: China EM&S QA 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：
1. 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
- 确保对物料（原料药、辅料和包装材料）进行入厂质量控制，并定期对CMO的检验结果进行抽查复核，确保相关物料符合药品要求和法律法规标准Ensure management of Incoming Quality Control of materials (API, Excipients and Packing materials), and regularly conduct spot check review of Incoming Quality Control results of CMO to ensure that the relevant materials meet pharmaceutical requirements and legal Specifications
- 共线生产线的质量风险管理：确保为受托产品制定并实施交叉污染控制措施，保障产品质量安全Quality risk management of co-production line: Ensure the formulation and implementation of cross-contamination control measures for the entrusted product, and to ensure product quality safety
- 支持QAI定期对合同生产企业质量管理体系进行现场检查，确保持续符合法律法规要求Support QAI regular on-site inspection of the QMS of Contract Manufacturing Enterprise to ensure that it continues to comply with legal requirements
- 作为MAH质量部门与外部CMO之间的联络人，及时传达公司的质量要求和期望；与CMO保持良好沟通，及时掌握其供应链的变化；建立有效的信息反馈渠道，能够快速响应潜在问题As a liaison between the MAH quality department and the external CMO, convey the company's quality requirements and expectations in a timely manner; Maintain good communication with CMO to keep abreast of changes in their supply chain in a timely manner; Establish an effective information feedback channel to quickly respond to potential problems
2. 主要物料、中间产品及成品的取样分析Sampling analysis of key materials, intermediates and finished products
- 确保开展抽样分析，包括定期抽样分析以及因重大偏差、重大变更或显著不良趋势而触发的抽查分析The conduct of spot analysis shall be ensured, including regular spot analysis and the spot inspections triggered by significant deviation, major change, major adverse trend
- 确保质量控制实验室的合规性，并监督合同检验全过程Ensure the compliance of the quality control laboratory and supervise the whole process of Contract Analysis
3.产品放行Product release
- 确保所有待上市产品在放行前均经过严格审核，包括批次分析记录、批生产记录、偏差处理、OOS（超标结果）调查等，以实现产品质量目标，确保产品符合GMP要求和注册标准Ensure that all products to be marketed have been strictly reviewed before release, including batch analysis records, batch production records, deviation handling, OOS investigation, etc., to achieve the product quality target and comply with GMP requirements and registered specification
- 药品追溯基本信息的维护与关联关系上传Maintain product traceability basic information and upload aggregation information file
- 必要时，质量负责人（质量授权人）的转授权人进行相关工作if needed, as the delegation of Quality responsible person (Qualified person to perform the relevant work
- 对退货产品/不合格产品进行评估并做出决定，负责不合格品的监督销毁Assess and make decision for the return goods/ rejection, responsible for the supervision of rejected materials destruction
4.其他活动Other activities
- 审批验证相关文件Review and approve validation related documents
- 跟进已放行/分销产品和货架期结束前长期稳定性研究中确认的超出规格(OOS)结果，并协调任何相关的监管行动For the follow up of confirmed Out of Specification (OOS) results on released/distributed product and on long term stability studies that occur prior to end of shelf life and coordinating any related regulatory actions
- 支持识别、评估、控制和沟通涉及职责范围内组分、原材料和成品药物的风险To support identification, assessment, control and communication of risks involving components, raw materials, and finished pharmaceuticals within scope of responsibility
- 确保偏差和变更控制活动得到一致且及时的管理To ensure that the deviation and change control activities are consistently and timely managed
- 确保实施和评估纠正和预防措施以解决系统性问题To ensure implementation and evaluation of corrective and preventive actions to address systemic issues
- 跟进（潜在的）可报告事件For the follow up of (potential) reportable events
- 支持组织职责范围内CMO（委托生产商）的审计管理，以及与全球审计和供应商管理运营部(SMO)合作执行审计To support the organization of an audit management program of CMOs within scope as well as audit program execution in cooperation with global audit program and Supplier Management Operations (SMO)
- 确保准确、及时且符合GMP要求地实施职责范围内CMO生产的技术产品投诉的生产调查Ensure accurate, timely, and GMP-compliant implementation of manufacturing investigations for technical product complaints from CMO production within the scope of responsibility
- 支持实施自检和持续改进工具To support the implementation of self-evaluation and continuous improvement tools
- 负责职责范围内产品的产品质量回顾(PQR)的撰写Prepare Product Quality Reviews (PQRs) of products in scope
- 支持CMO和供应商审计流程以及自检，包括与其他职能部门合作进行规划、组织、执行、报告和跟进To support the CMOs and supplier auditing process as well as self-inspections including planning, organization, performing, reporting and follow-up in cooperation with other functions
- 召回决定的跨部门沟通Cross-functional communication of the Recall Decision
- 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，从事过药品生产过程控制和质量检验工作。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, with experience in pharmaceutical production process control and quality inspection work. 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!