Job Description

Job title职位名称 QC Support Manager

• Location工作地点： Beijing北京

About the job工作职责

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as QC Support Manager within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.

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：

• Overseeing all quality processes and digital solutions related to quality control management in compliance with the Sanofi global processes and quality control tools

• Providing QC support for all routine activities

• Leading the quality control schedule and capacity planning to support the timely release of products and the adherence of the test’s execution to the committed standard times

• Defining and maintaining the maintenance, qualification, and calibration plans to ensure valid status of the lab equipment

• Managing reference standards and reagents for the labs

• Training management of quality control samplers or warehouse/manufacturing samplers when delegated

• Owning stability studies managed by the site in compliance with approved protocols: testing executed in a timely manner and stability result trending performed on time, including reports issuance

• Providing the appropriate quality control documentation defined in accordance with the Sanofi global processes

• Implementing and maintaining QC digital solution (core model and local) (including data management and end-user management)

• Managing and training QC support team

• Leading initiatives for continuous improvement in QC support processes in coordination with QC Excellence team

• Ensuring a quality control process supported by appropriate procedures is implemented in line with global quality and maintained locally in compliance with regulatory requirements

• Ensuring the consolidated follow-up and progress tracking of events (e.g., deviation, lab investigations), change control, CAPAs, related to QC, coordinating with respective QC areas and other involved functions, to ensure they are managed and closed as committed

• Overseeing the Business Owners for QC processes by having QC representatives of the site in the CoPs led by global, and if requested participating in the CoEs, and ensuring local communication

• 根据赛诺菲的全球流程和质量控制工具，监督与质量控制管理相关的所有质量流程和数字解决方案

• 为所有日常活动提供 QC 支持

• 领导质量控制计划和能力规划，以支持产品的及时放行以及测试执行符合承诺的标准时间

• 定义和维护维护、验证和校准计划，以确保实验室设备的有效状态

• 管理实验室的参照标准品和试剂

• 授权时对质量控制采样员或仓库/制造采样员进行培训管理

• 负责由工厂按照批准的方案管理的稳定性研究：及时执行测试，并按时执行稳定性结果趋势分析，包括报告发布

• 提供根据赛诺菲全球流程定义的适当质量控制文档

• 实施和维护 QC 数字解决方案（核心模型和本地）（包括数据管理和最终用户管理）

• 管理和培训 QC 支持团队

• 与 QC Excellence 团队合作，领导持续改进 QC 支持流程的举措

• 确保根据全球质量实施由适当程序支持的质量控制流程，并根据监管要求在当地进行维护

• 确保对与 QC 相关的事件（例如偏差、实验室调查）、变更控制、CAPA 进行统一的跟进和进度跟踪，与相应的 QC 领域和其他相关职能部门协调，以确保按照承诺进行管理和关闭

• 通过在全球 CoP 中由工厂的 QC 代表领导，并应要求参与 CoE，并确保当地沟通，监督 QC 流程的业务责任人

About you 任职资格

Bachelor degree or above in chemistry, pharmacy or relative majors with minimum of 3 years related work experience.

化学、制药或相关专业学士学位,至少3年相关工作经验

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!