Manufacturing and Supply
Where the
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Job Information职位信息

Job title职位名称: Senior Product Quality Specialist

• Location工作地点： Shanghai, China   中国上海
• % Remote working and % of travel expected 远程办公和出差的概率：5%
• Job type工作类型: Permanent长期, Full time全职
• Site/Unit 区域/事业部：M&S 制造与供应事业部

About the job工作职责

Our Team我们的团队：

Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.

制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。

Main responsibilities职责描述：

Please indicate here the main job responsibilities请列举该职位的主要工作职责。

Key Mandatory Accountabilities of Management of the Country Quality System:

分公司质量体系管理的主要职责包括：

• Design, implement, manage and control a Country Quality system for GxP and health-regulated activities from development to commercialisation of all products and related GxP services, in compliance with Sanofi quality documents and standards, as well as applicable local regulatory requirements.
• GxP 服务从开发到商业化涉及的GxP和卫生监管活动制定、实施、管理和控制一个有效的分公司质量体系。
• Enhance Quality culture & promote Quality mind-set into the country governance, working principles and ways of operating.

强化质量文化，在分公司治理、工作原则和经营方式中树立质量思维。

• Ensure appropriate communication of key messages pertaining to Quality across the country organisation, highlighting their possible business impact.

确保与质量相关的关键信息在整个分公司组织内进行适当的沟通，强调其可能对业务产生的影响。

• Lead and coordinate a network of professionals designated in each country function involved in GxP and health-regulated activities and embark them to address all matters related to Quality, including the support to business and digital initiatives.

组织和协调分公司职能部门中指定参与GxP和卫生监管活动的专业人员网络，并启动他们处理与质量相关的所有事务，包括对业务和数字举措的支持。

• Design and implement quality management system evolving strategy for all affiliate entities to ensure compliance with China MAH (Market Authorization Holder) & MAHD (Market Authorization Holder Domestic Responsible Entity) Regulation in China Mainland.

为所有分公司实体制定和实施质量管理体系发展战略，确保符合中国大陆的 MAH（药品上市许可持有人）和MAHD（药品上市许可持有人境内责任人）法规。

• Contribute China MAH project with global & local stakeholders covering all GBU/Entities to ensure compliance with global quality requirement as well as local regulation requirement.

支持中国 MAH 项目，与全球和本地利益相关者合作，涵盖所有GBU/实体，确保符合总部质量要求以及本地法规要求。

• Contribute China quality organization evolving to match with MAH/MAHD new regulation requirement.

支持中国质量组织发展，以符合 MAH/MAHD 新法规的要求。

• Country Quality documentation management system  分公司质量文件管理系统：
  • Provide guidance to country functions that need to develop or update Country Quality documents and related training modules in their respective domains.

为需要在各自领域内建立或更新分公司质量文件和相关培训模块的分公司职能部门提供指导。

• Ensure that required quality documents are in-place, in-use and up-to-date at country level, providing oversight of GxP areas.

确保必要的质量文件在分公司层面的建立、实施和更新，从而对GxP领域进行监督。

• Country Quality audits and GxP regulatory country inspections分公司质量审计和GxP监管分公司检查：
  • Provide support to ensure continuous audit and country inspection readiness, using the Inspection Readiness Tools for Country Organisations.

提供支持以确保可持续的审计和分公司检查准备工作，通过使用分公司组织检查准备工具。

• Manage country regulatory inspections related to GxP processes owned by the CQH and provide support and coordination with other GxP country functions in country regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level, as needed.

管理CQH负责的GxP流程的分公司监管检查，并在分公司监管检查中与其他GxP分公司职能部门一起支持和协调其各自职责范围内的流程，确保赛诺菲集团总部相关的职能部门在需要时提供协助。

• Where applicable and required by local regulation and/or expectations of the local Regulatory Authorities, in conjunction with Regulatory Affairs, support the HA in their GMP inspections of foreign sites. If required, and as agreed at MCCQ level, accompany the HA inspectors on their site visits.

在适用的情况下，根据本地法规和/或本地监管机构的期望，与药政事务部合作，支持卫生监管部门对境外工厂的GMP检查。如有需要，按照MCCQ的约定，陪同卫生监管部门的检查人员进行现场检查。

• Define and implement a strategy for local audits, based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the country. Assure the coordination of the execution of audits managed at country level.

根据风险管理标准，定义并实施由分公司直接管理的涉及本地GxP和卫生监管活动的关键分包商的本地审计策略。确保协调在分公司层面管理的审计的执行。

• According to local specific needs and regulatory requirements, enrol and complete the Sanofi auditor certification program to conduct local audits.

根据本地的具体需求和法规要求，注册并完成赛诺菲审计员认计划，以进行本地审计。

• Evaluate trends in local quality audit findings that may affect the Country Quality system and communicate audit findings that require improvement to the appropriate global functions.

评估可能影响分公司质量体系的本地质量审计发现项的趋势，并将需要改进的审计发现项传达给合适的总部职能部门。

• Ensure that local critical and major pharmacovigilance or safety related audit findings are managed as per global Sanofi requirements.

确保根据赛诺菲的总部要求管理本地严重和重大的药物警戒或安全相关的审计发现项。

• Act as the primary country contact for GxP system quality audits and support Global Quality Audit teams in their preparation, conduct and follow-up.

作为GxP体系质量审计的主要分公司联系人，并支持集团总部质量审计团队的准备、实施和跟进。

• Remain up-to-date on GxP system quality audit reports concerning the country, including any conclusions, decisions made, as well as actions plans.

及时了解分公司的GxP体系质量审计报告，包括结论、决策以及行动计划。

• Country Quality Review分公司质量回顾：
  • Carry out an annual Country Quality Review and organise the related meeting to present the outcomes to Country Senior Management, as per global Sanofi requirements.

根据赛诺菲总部要求，开展年度分公司质量回顾并组织相关会议，向分公司高级管理层展示结果。

• Issue the associated Annual Country Quality Review report and monitor the related Quality Program and Action Plan follow-up.

发布相关的年度分公司质量回顾报告，并监控相关的质量计划和行动计划的跟进。

• Deviation and Corrective-Preventive Actions (CAPA) management偏差和纠正预防措施（CAPA）管理：

define and implement a process to timely manage deviations and CAPAs related to all GxP and health-regulated activities, including those related to audits and country inspection findings, across the country in a consistent manner, and train concerned associates accordingly.

定义并实施一个流程，以一致的方式及时管理与所有GxP和卫生监管活动相关的偏差和CAPA，包括与审计和分公司检查发现项相关的偏差和CAPA，并相应地培训相关员工。

• Change Control management变更控制管理：

set a process to manage proposed changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary

通过领导多学科交流、必要时实施风险评估和行动计划，设定一个流程以管理可能影响GxP或卫生监管流程或运营的拟议变更。

• Country Quality Performance Indicators (QPI)分公司质量绩效指标（QPI）：

monitor and periodically report country QPIs defined by Global Quality using the appropriate Global Quality computerised system. In addition, define and follow-up on local QPIs, when relevant.

使用合适的总部质量计算机化系统监控并定期报告由总部质量部门定义的分公司QPI。此外，在相关时定义和跟进本地 QPI。

• Self-inspection自检/内审：

Implement self-inspection per approved plan as auditor or auditee.

作为审计员或受审方按照批准的计划进行自检查/内审。

• Country Quality Agreements分公司质量协议：

ensure that valid and signed quality agreements (with the country as contract giver) are in place with the appropriate Sanofi manufacturing sites and/or external organizations for all GMP activities under the responsibility of Quality within the country organisation.

确保与合适的赛诺菲生产工厂和/或外部组织签订有效并签字的质量协议（由分公司作为合同提供方）用于分公司组织内质量部门负责的所有GMP活动。

• Other service agreements其他服务协议：

ensure that quality clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities.

确保参与GxP和卫生监管活动的所有分包商的服务协议中都包含了质量条款。

• Quality oversight of locally managed GxP subcontractors对本地管理的GxP分包商进行质量监督：

ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved in selection process, qualification and performance of audits) or through coordination with the concerned country functions, as appropriate.

确保对本地管理的分包商参与的所有GxP和卫生监管活动有合适的质量监督流程，无论是直接（参与审计的选择过程、资质认证和执行）还是通过相关分公司职能部门协调，视情况而定。

• Quality risk management质量风险管理：
  • Be the focal point in the country for proactive and reactive Quality Risk Management matters.

作为分公司主动和被动质量风险管理事务的协调人员。

• Ensure that quality risks are properly managed within the country (identification,  assessment, control, communication).

确保质量风险在分公司得到妥善管理（识别、评估、控制、沟通）。

• Provide risk management expertise to other country functions as appropriate.

根据实际情况向其他分公司职能部门提供风险管理专业知识。

• Non-product related quality events非产品相关的质量事件：

escalate and manage the events occurring at the country according to defined processes and standards

根据规定的流程和标准上报和管理分公司发生的事件。

• Administrative records行政记录：

ensure availability of up-to-date administrative records (e.g. CV, job description, training log) for Country Quality associates, as well as updated Country Quality organisational charts - and provide guidance to GxP and health regulated areas be compliant with this requirement.

确保提供分公司质量部门员工最新的管理记录（例如简历、工作描述、培训记录），以及最新的分公司质量部门组织架构，并为GxP和卫生监管领域提供符合此要求的指导。

• Computerised systems (CS)计算机化系统（CS）：

maintain an up to date local inventory of GxP CS and GxP spreadsheets and guarantee they are validated by the relevant ITS functions. In addition, assure that non-ITS computerised systems in use within the country for GxP activities are validated by the system owner and in compliance with regulations and standards.

维护最新的GxP计算机化系统和GxP电子表格的本地清单，并保证它们经过相关ITS职能部门的验证。另外，确保在分公司用于GxP活动的非ITS计算机化系统经过系统所有者的验证，并符合法规和标准的要求。

• Projects项目：

lead and coordinate Quality projects. Provide Quality support to new business areas (e.g. acquisitions & divestments) and implementation of digital initiatives, including e-tools.

领导和协调质量项目。为新的业务领域（例如收购和撤资）和实施数字举措（包括电子工具）提供质量支持。

• Quality Intelligence  质量情报：
  • Establish, maintain and improve quality intelligence process on China GxP Regulation or technical guidelines for all Business through global quality intelligence network & experts.

通过集团总部质量情报网络和专家，建立、维护和改进中国GxP法规或所有业务技术指南的质量情报流程。

• Ensure local process and system compliant with China GxP regulation through gap assessment and action taken if necessary.

通过差距评估并在必要时采取行动，确保本地流程和系统符合中国GxP法规。

• External reach out activities such RDPAC Quality working group, ISPE and CPAPE, etc.

外部联系活动，如RDPAC质量工作组、ISPE和CPAPE等。

• Regulatory advocacy with China Health Authority when necessary.

必要时与中国卫生局进行法规宣传。

Key Mandatory Accountabilities of Quality of Products:

产品质量管理的主要职责包括：

• China MAH/MAHD Post-market Quality Obligation Implementation  中国药品上市许可持有人/境内责任人上市后质量义务的实施：
  • Establish, maintain and implement related quality process for China MAH/MAHD regulation compliance, including but not limited to:

建立、维护和实施符合中国药品上市许可持有人/境内责任人法规要求的相关质量流程，包括但不限于：

• Market Release by MAH/MAHD according to China regulation and ensure product quality in compliance with Chinese registered specification.
• /境内责任人根据中国法规进行市场放行，并确保产品质量符合中国注册规范。
  • Annual product report according to China DAL, VAL & MAH related regulations.
• • Quality communication with varied manufacturing sites and global quality for product quality.
• • Product traceability management.
• • Interaction with China health authority.

• New Product Launch  新产品上市：
  • As quality expert, to guide imported new product launch and ensure compliance with Sanofi global and China GxP requirement.

作为质量专家，指导进口新产品上市并确保符合赛诺菲集团总部和中国GxP法规的要求。

• Provide China GxP regulation interpretation support for all sites to ensure new product marketed in China compliance with China GxP regulation requirement.

为所有工厂提供中国 GxP 法规解读的支持，以确保在中国销售的新产品符合中国 GxP 法规要求。

• Support early access projects to boost the product to market.

支持先行先试准入项目，将产品推向市场。

• Quality Inquiry  质量问询：

Manage quality inquiries received from the market according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functions.

根据赛诺菲现行的流程、标准和适当的工具，与相关的总部质量职能部门合作，管理从市场收到的质量问询。

• Product-related Quality Events  产品相关的质量事件：
  • Escalate quality events as necessary occurring at the country level according to defined processes and standards and manage subsequent quality and product alerts (as appropriate).

按照规定的流程和标准，必要时在分公司层面上报发生的质量事件，并管理后续的质量和产品警报（如适用）。

• Provide support to the appropriate functions at country level and according to the defined responsibilities vis à vis Regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events).

根据监管机构的明确职责（例如，质量授权人、药政事务部门，负责管理与产品相关的质量事件的通知和与监管机构的沟通），为分公司层面合适的职能部门提供支持。

• Other relevant Quality tasks, where applicable  其它相关的质量工作（需要时）：
  • Perform local market batch release (batch disposition).

执行本地市场批次放行（批次处置）。

• Ensure quality oversight of any other quality activity deemed necessary as per country regulation (e.g. Quality Control analysis, analytical transferences, pharmacovigilance).

确保根据分公司法规，对任何其他被认为必要的质量活动（例如质量控制分析、分析转移、药物警戒）进行质量监督。

• Provide Quality oversight of local Contracted Manufacturing Organizations (CMO), if applicable.

如适用，对本地合同生产组织（CMO）进行质量监督。

Act as the back-up of Rong Heng Quality Specialist, Key Mandatory Accountabilities of GSP quality management part:

作为荣恒医药质量专员的后备，承担GSP质量管理还包括以下主要职责：

• Country Quality documentation management system分公司质量文件管理系统：
  • Organise a consistent management of Country Quality documents related to GxP and health-regulated activities through an appropriate system.

通过合适的系统对与 GxP 和卫生监管活动相关的分公司质量文件进行一致的管理。                                                                 

• Country Quality audits and GxP regulatory country inspections分公司质量审计和GxP监管分公司检查：
  • Assure that country inspections of GxP or health-regulated areas are reported by the relevant GxP function in the appropriate company global database.

确保相关GxP职能部门在合适的公司总部数据库中报告GxP或卫生监管领域的分公司检查。

• Training 培训：
  • Organise and manage information sharing, training sessions or programs related to processes under the responsibility of the CQH for concerned country associates, according to Sanofi standards and regulatory requirements.

根据赛诺菲标准和法规要求，为相关的分公司员工组织和管理与CQH职责范围内的流程相关的信息共享、培训课程或计划。

• Ensure that there are system, process and procedure in place for the management of GxP & health-regulated trainings across the country by each GxP & health-regulated Function (CQH oversight on trainings owned by GxP & health-regulated Functions).

确保每个GxP和卫生监管职能部门在分公司范围内都有管理GxP和卫生监管培训的体系、流程和程序（CQH对GxP和卫生监管职能部门所负责的培训进行监督）。

• Country Quality Agreements分公司质量协议：
  • Ensure that valid and signed quality agreements (with the country as contract giver) are in place with the appropriate Sanofi distribution sites and/or external organizations for all GDP activities under the responsibility of Quality within the country organisation.

确保与合适的赛诺菲分销中心和/或外部组织签订有效并签字的质量协议（由分公司作为合同提供方）用于分公司组织内质量部门负责的所有GDP活动。

• Product-related quality events产品相关的质量事件：
  • Provide support to the appropriate functions at country level and according to the defined responsibilities vis à vis Regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events).

根据监管机构的明确职责（例如，质量授权人、药政事务部门，负责管理与产品相关的质量事件的通知和与监管机构的沟通），为分公司层面合适的职能部门提供支持。

• Ensure quality oversight on management of product distribution issues, including temperature excursion.

确保对产品分销问题（包括温度偏移）的管理进行质量监督。

• Final approval quality qualification of first commercial enterprise and first commercial product with independent right of rejection in Rong Heng DC and take main responsibilities of product quality management within Rong Heng DC scope.

最终批准（具有独立拒绝权）荣恒DC的首家商业企业和首个商业产品的质量资质，并承担荣恒DC范围内的产品质量管理的主要责任。

• Validation验证：
  • Manage the validation that may impact GSP/GDP process or operations by leading multidisciplinary exchanges and actions plans when necessary.

必要时，通过领导多学科交流和行动计划，管理可能影响GSP/GDP流程或运营的验证。

• Importer Management 进口商管理：
  • Sanofi products importer management.

赛诺菲产品进口商管理。

• Other relevant Quality tasks, where applicable其他相关的质量工作（需要时）：
  • Perform vaccines customer certification.

执行疫苗客户认证。

• Ensure distributor’s license and relevant information can meet GSP requirements.

确保经销商的许可证和相关信息符合GSP要求。   

• Ensure quality oversight of distributors (buy and sell products partners) and external wholesaler distributors (importers).

确保对经销商（采购和销售产品合作伙伴）和外部批发商经销商（进口商）进行质量监督。

• Ensure quality oversight of any other quality activity deemed necessary as per country regulation (e.g. Quality Control analysis, analytical transferences, pharmacovigilance).

确保根据分公司法规，对任何其他被认为必要的质量活动（例如质量控制分析、分析转移、药物警戒）进行质量监督。

• Assure that any local GMP/GDP activities (e.g. manufacturing, repackaging, storage, distribution, testing, etc.) are performed in accordance with applicable GMP and GDP regulations.

确保任何本地的GMP/GDP活动（例如生产、二次包装、储存、分销、测试等）均按照适用的GMP和 GDP法规进行。

• Depending on the country organisation, manage and make decisions in case of temperature excursion during storage or transport in case of locally managed distribution subcontractor.

根据分公司的组织，在本地管理的分销分包商的情况下，管理并决定储存或运输过程中的温度偏移。

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。

• Experience:

Experience in pharmaceutical is preferred.有制药行业经验者更佳。

• Soft and technical skills:

Soft Skills通用技能： Act for Change 勇于变革、Advanced Commit to Customer 对客户的承诺（高级）、Cooperate transversally 广泛合作、Strive for results 力求结果

Technical Skills专业技能：GxP and health-regulated Regulations (GMP, GDP) 生产质量管理和经营质量管理、Quality Systems质量体系、Quality Risk Analysis 质量风险分析

• Education:

University degree or equivalent in Pharmaceutical Engineering, Bioscience, Chemistry, or relevant subjects.制药工程、生物科学、化学或相关专业大学学士或同等学历。

• Languages:
• luent in Chinese and English reading, speaking and writing. 能够熟练地应用中文和英文进行书面和口头的阅读理解、写作、交流。

• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi

全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致

Why choose us? 为什么选择赛诺菲？

Add four standard Sanofi selling points and up to three additional selling points that are specific to the role, team or location.

•      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.

•      Play an instrumental part in creating best practice within our manufacturing facility

Pursue progress, discover extraordinary进无止境，探索菲凡

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。

在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。

观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com