M&S-Head of Quality Control-Beijing

Job title职位名称:

Head of Quality Control质量控制经理

• Location工作地点： Beijing

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：

1. Manage the Laboratories ensuring that the equipment and

instruments are functional

(calibrated/qualified, and well maintained, availability of consumable) and suitable for analytical testing.

管理实验室，确保设施和仪器适合分析测试（得以校准/确认和良好的保养，足够的实验耗材）。

2. Ensure proper preparation and maintenance of laboratory documents such as Analytical Methods, Specifications, Standard Operating Procedures, etc.. Monitor and ensure proper preparation for Protocols and ensure the Qualification of the laboratory equipment/instruments and the Validation of new Analytical Methods is performed accordingly.

确保对实验室分析方法、质量标准、标准操作规程等文件执行良好地准备和维护。监督和确保实验室准备合适的方案并确保实验室仪器设备的确认和新的实验方法的验证依照方案执行。

3. Manage workload and resources to ensure timely and compliantly finish QC responsible manufacture related activities such as testing of incoming materials, sample testing of IPC, intermediates, semi-finished products, finished products, stability, cleaning verification, method and specification establishment and maintenance, project transfer, environment testing, investigations, maintain the working microbial bank, and related auxiliary material release.

合理安排工作量及资源以确保及时合规的完成 QC负责的生产相关各项活动，如来料，IPC，中间体、半成品、成品、稳定性样品、清洁确认检验，方法和质量标准维护管理和监控样品的取样和分析，确保执行的检测符合质量标准的建立及维护，项目转移，环境检测，调查，菌种库维护，相关辅助性物料放行。

4. Ensure that Reference Standards as well as Standard Solutions are suitable and maintained according

to the GMP. Maintain and control the inventory of test material and consumables ensuring the availability and control the cost within budget scope.

确保标准品和标准试剂适当并按照GMP要求进行保管。保管和控制耗材试剂，确保其可供持续使用并控制在预算范围内。

5. Ensure lab pertinent samples, materials and products are correctly labeled.

确保实验室相关的样品，物料，产品进行了正确的标识。

6. Ensure root cause of investigation of lab scope is identified scientifically and appropriately and the CAPAs of lab are made and implemented effectively.

确保实验室范围的调查，其根本原因科学合理的识别并确保实验室的纠正预防措施有效制定实施。

7. Ensure stability and the retention samples are managed timely and meet requirements.

确保稳定性和留样的管理及时并符合要求。

8. Keep close relationship and communication with other departments to ensure proper execution of the production plan and EM plan. Lead and motivate the analysts for a continuous improvement of GMPs as

well as HSE awareness.

与相关部门保持密切联系和沟通以确保生产计划和环境监控计划的执行。领导并激励实验室人员不断改进和完普GMP和环境/健康/安全程序。

9. Ensure GAP analysis for global requirement and local authority standard are timely implemented and take CAPA actions.

确保及时执行总部要求及本地法规标准的差距分析，并且实施纠正预防措施。

10. Support new Project and continuously improvement. Contribute to internal & External inspections.

支持新的项目及持续改善；接受内外部审计的工作。

11. Approve and monitor any contract analysts.

批准和监控委托检验。

12. Develop people via training and coaching to enable them qualified for lab test work. Training curriculum up to date. Ensure new associates trained according to the training curriculum.

发展人员，使他/她们能够符合实验室工作要求。按照计划的要求实施培训，并保证培训及时更新。

13. Perform people performance management. Make individual develop plan with personnel within team and build up technical ladder.

进行人员绩效管理。制定团队的个人发展计划，建立人才梯队。

14. Responsible for QC function budget following the site strategic policy and control the implementation.

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: with minimum 6 years’ experience in analytical methodologies and management.

工作经验: 至少6年以上实验室分析和相关管理工作经验。

• Soft skill: must be problem solving oriented.

通用技能: 需具备善于解决问题的能力和主动性。

• Technical skill: Must have good knowledge of  Chinese and international GMP  related to GMP labs.

专业技能: 要求了解中国和国际GMP实验室相关要求。

• Education: A degree in pharmacy, chemistry and biology or other related disciplines.

教育背景: 药学、化学、生物相关专业学士及以上学位。

• Languages: Good English spoken & written。

语言要求: 英语口语和书写熟练

• 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?

• 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 video and check out our Diversity Equity and Inclusion actions at sanofi.com!