Job Information 职位信息
Job title职位名称: Quality Specialist 质量专员
- 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：N/A
- Job type工作类型: Full time全职
- Site/Unit 区域/事业部：Beijing Site/ M&S China北京工厂/中国制造与供应事业部
About the job工作职责
Our Team我们的团队：
The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools.
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。
• Ensure all distribution and marketing activities of products operated by Sanofi entities in China are in compliance with Sanofi Quality Policy, Quality Standards and applicable regulatory requirements.确保赛诺菲在中国运营的所有产品的分销和营销活动符合赛诺菲质量政策、质量标准及适用的法规要求。
• Manage quality processes and perform quality control activities as defined in procedures, especially those established in accordance with current GSP/GDP regulations.管理质量流程并执行程序中定义的质量控制活动，特别是根据现行GSP/GDP法规建立的相关活动。
• Provide strong quality support to innovation and business initiatives, including digital transformation projects. 从质量角度为创新和业务举措（包括数字化转型项目）提供有力支持。
• Promote a quality culture and quality mindset across the organization, ensuring compliance with both global Sanofi standards and local Chinese regulatory requirements. 在整个组织中推广质量文化和质量思维，确保符合赛诺菲全球标准和中国本地法规要求。
Main responsibilities职责描述：
The Quality Specialist operates within the China Quality organization, reporting to the Quality Manager (GSP). The role supports GxP and health-regulated activities across the full product lifecycle — from development to commercialization — with a primary focus on GSP/GDP compliance. The position works cross-functionally with local business units, global quality teams, regulatory authorities, and external partners including distributors, importers, and subcontractors. 质量专员在中国质量组织内工作，向GSP质量经理汇报。该职位支持产品全生命周期（从开发到商业化）中的GxP和卫生监管活动，重点关注GSP/GDP合规性。该职位需与本地业务部门、全球质量团队、监管机构以及经销商、进口商和分包商等外部合作伙伴进行跨职能协作。
职责描述
Management of the Quality System 质量体系管理：
- Define, implement, manage and control 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.定义、实施、管理和控制GxP和卫生监管活动的质量体系，覆盖所有产品和相关GxP服务从开发到商业化的全过程，确保符合赛诺菲质量文件、标准及适用的本地法规要求。
- Enhance Quality culture & promote Quality mind-set into the governance, working principles and ways of operating (focus on GSP/GDP).强化质量文化，在治理、工作原则和运营方式中树立质量思维（重点关注GSP/GDP）。
- Ensure appropriate communication of key messages pertaining to Quality across the organisation, highlighting their possible business impact.确保质量相关关键信息在整个组织内进行适当沟通，强调其对业务可能产生的影响。
- Manage GSP/GDP Documents and Records per local regulation and requirements, considering data integrity principles, implement the Documentation Management system per local requirement.按照本地法规要求和数据完整性原则管理GSP/GDP文件和记录，并根据本地要求实施文件管理系统。
- GSP/GDP Quality audits and regulatory inspections: GSP/GDP 质量审计和监管检查：
- Provide support to ensure continuous audit and inspection readiness.提供支持以确保持续的审计和检查准备状态。
- Manage regulatory inspections related to GSP/GDP processes owned by the CQH and provide support and coordination with other GxP functions in 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GSP/GDP流程的监管检查,并在监管检查中与其他GxP职能部门协调配合其各自职责范围内的流程,确保集团总部相关职能部门在需要时提供支持。
- Assure that inspections of GSP/GDP are reported by the relevant GxP function in the appropriate company global database.确保GSP/GDP检查由相关GxP职能部门在公司全球数据库中进行适当报告。
- According to local specific needs and regulatory requirements, enroll and complete the Sanofi auditor certification program to conduct local audits.根据本地具体需求和法规要求,注册并完成赛诺菲审计员认证计划以进行本地审计。
- Evaluate trends in local quality audit findings that may affect the Quality system and communicate audit findings that require improvement to the appropriate global functions.评估可能影响质量体系的本地质量审计发现项趋势,并将需要改进的审计发现项传达给相应的全球职能部门。
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 Review 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。
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 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。
- 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。
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：
- 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。
- Regulatory advocacy with China Health Authority when necessary.
必要时与中国卫生局进行法规宣传。
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。
- 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。
New Product Launch 新产品上市：
- Support early access projects to boost the product to market.支持早期准入项目，将产品推向市场。
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 其它相关的质量工作（需要时）：
- 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。
- 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:
Experience 工作经验
- 1-3 years plus working experience in pharmaceutical industry, preferable in MNCs GSP/GDP/GMP area.制药行业1-3年及以上的工作经验，有跨国药企GSP/GDP/GMP领域工作经验更佳；
- Experience in interacting with health authorities, industry associations.有与卫生监管部门，行业协会互动的经验；
- Some QC experience in Bio-Pharm product is plus.具有生物制药产品质量控制经验者更佳。
- A Licensed Pharmacist is a plus,持有药剂师证者更佳
Education 教育背景
- Bachelor's degree or above in Pharmacy, Medicine, Biology, Chemistry or related subjects, OR junior or above professional technical title in Pharmacy.具有药学或者医学、生物、化学等相关专业大学本科及以上学历或者具有药学初级以上专业技术职称。
Soft skills 通用技能
- Good communication skills. 良好的沟通能力
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Basic 基础
Languages 语言
- Fluent 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
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。
Take The Lead Behaviours：Aim Higher、Act for Patients、Be Bold and Lead Together
引领前行行为：更高目标、以患者为本、勇于创新、共同领导
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!
