M&S-Country Quality Supervisor-Shanghai

Job title职位名称: Country Quality Supervisor

• 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：

Management of the Country Quality Management System

分公司质量体系管理

• Implement, manage, and control a Country Quality Management system for GxP activities from development to commercialisation of all products and related GxP services, in compliance with Sanofi requirements, as well as applicable local regulatory requirements.

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• Participate in the Oversee of all country GxP operation and compliance (including PV, regulatory, market supply chain, medical, etc.) through robust quality management system, to ensure fulfilment of post-market management , GSP/GDP quality management and MAHD accountability.

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• Understand Quality culture and promote Quality mindset into the country governance, working principles, and ways of operating.

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

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• Assure that a process for management of GxP documents and records is in use in all GxP areas, considering data integrity and data privacy principles.

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Country Quality documentation system 本地质量文件系统：

• Organize a consistent life cycle management of Country GxP documents (except for Clinical Study Unit (CSU)) using the global content management system.

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• Ensure and coordinate across GxP functions the direct use of global documents or the creation of country GxP documents, based on the Advanced Content Template (ACT) in case of any regulatory requirement.

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Country Quality audits and GxP regulatory country inspections 本地质量审计和GxP监管检查：

• Collaborate to ensure country inspection readiness.

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• Participate in the Management of 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.

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• Where applicable, in accordance with local regulations and/or the expectations of local regulatory authorities, collaborate with the Regulatory Affairs, Pharmacovigilance, and other relevant functional departments to support regulatory inspections of marketing authorization holders, overseas sites, and MAHD(s).

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• Implement a strategy for local quality audits, based on Quality risk management criteria, of key local GxP service providers directly managed by the country, including the outsourced hybrid processes (non-GxP processes with GxP impact) with safety reporting components.

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Personnel Qualification and Training 人员资质和培训：

• Organize information sharing, training sessions or programs related to processes under the responsibility of the CQH for concerned country associates, according to Sanofi and regulatory requirements.

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• Ensure that there are system, process and procedure in use for the personnel qualification (e.g. CV, job description, training curricula and records) and the management of GxP trainings across the country by each GxP function.

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Country Quality Review分公司质量回顾：

• If required by local regulations, support the Annual Country Quality Review as per Sanofi requirements.

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Deviation and CAPA management偏差和CAPA管理：

• Ensure that a process to timely manage deviations and CAPAs related to all GxP activities across the country is in use in a consistent manner.

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Change Control management变更控制管理：

• Ensure that a process is in use across the country to manage proposed changes, that may impact GxP processes or operations, implementing risk assessment and action plans when necessary.

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Country Quality Performance Indicators (KPI) 质量绩效指标（KPI）：

• Monitor MCO/country KPIs defined by Global Quality using the appropriate Global Quality computerised system.

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Self-inspection自检/内审：

• Ensure compliance to the local requirements for self-inspection.

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• Implement a self-inspection process and program to meet regulatory requirement and enable continuous improvement and GxP inspection readiness.

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Quality risk management质量风险管理：

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

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

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 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 procedures.

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Computerized Systems (CS) and Digital Properties 计算机化系统（CS）和数字化工具：

• Maintain an up-to-date local inventory of GxP CS (exception for CSU) and digital properties and check if the locally owned GxP CS are validated as per Sanofi requirements and address any identified gaps accordingly.

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Projects项目：

• Collaborate Quality projects. Provide Quality support to new business areas (e.g. acquisitions and divestments, products launch readiness) as needed.

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Quality Intelligence质量情报：

• Implement a screening process for released local regulations to capture the requirements that must be transcribed into Country Quality documents. Ensure local process and system compliant with China GxP regulation through gap assessment and action taken if necessary.

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Quality Communication质量沟通：

• Support quality culture relevant activities, e.g., World Quality Week, Greater China Quality Community to foster prosperous dialogue.

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Quality Evolution 质量进化：

• Act as the local advocator to drive and support quality evolution in organization modernization and digitalization, by introducing mature digital tools into quality operation.

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Product Quality 产品质量

Product Complaints产品投诉：

• Manage product complaints received from the markets including suspicious product cases (when applicable) in coordination with the central PTC organization, where applicable.

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• Conduct product complaints’ trend analysis and signal detection, as per Sanofi requirements and local regulations, if applicable.

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Quality Inquiry质量问询：

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

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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 manage subsequent quality alerts and product alerts (as appropriate).

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• Coordinate product recalls as per global and local (where applicable) processes, including mock recalls if applicable.

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China MAH/MAHD Post-market Quality Obligation Implementation中国药品上市许可持有人上市后质量管理及境内责任人质量管理义务：

• Establish, maintain and implement related quality process for China MAH/MAHD regulation compliance, including but not limited to:

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• Annual product report according to China DAL, VAL & MAH related regulations.

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• Quality communication with varied manufacturing sites and global quality for product quality.

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• Product traceability management.

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• Interaction with China health authority.

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Validation验证：

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

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GMP and GDP Activities, where applicable GMP和GDP活动（需要时）：

• Perform supplier & customer certification.

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

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

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

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

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

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About you 任职资格:

Ø  Experience 工作经验

Experience in industrial or affiliate quality system management is preferred.

有工厂或商业质量体系管理经验者更佳。

Ø  Education 教育背景

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。

Ø  Soft skills 通用技能

Act for Change

勇于变革

Advanced  高级

Key 重要

Advanced Commit to Customer

对客户的承诺（高级）

Advanced  高级

Key 重要

Cooperate transversally

广泛合作

Advanced  高级

Key 重要

Strive for results

力求结果

Advanced  高级

Key 重要

Decision making

果断决策

Basic 基础

/

Develop people

人员发展

Basic 基础

/

Lead teams

团队领导力

Basic 基础

/

Think strategically

策略性思维

Basic 基础

/

Business Partnering

和业务部门展开合作

Basic 基础

/

Advanced Communication Skills

高级沟通技巧

Basic 基础

/

Internal and external networking capability

内部和外部的社交能力

Basic 基础

/

Leadership and assertiveness skills

领导力和自信力

Basic 基础

/

Advanced Negotiation and Influential skills

高级谈判技巧和影响力

Basic 基础

/

Advanced Problem solving

高级解决问题的能力

Basic 基础

/

Ø  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

Key 重要

GxP and health-regulated Regulations (GVP, GCP)

药物警戒质量管理和临床质量管理

Basic 基础

/

Quality Systems

质量体系

Advanced  高级

Key 重要

Continuous improvement management

持续改进管理

Advanced  高级

Key 重要

Quality Risk Analysis

质量风险分析

Basic 基础

/

Quality Risk Management

质量风险管理

Basic 基础

/

Project Management Skills

项目管理能力

Basic 基础

/

Ø  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。

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.

PursueProgress. 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 videoand check out our Diversity Equity and Inclusion actions at sanofi.com!