M&S-Supervisor of Quality Control Support-Beijing

Job title职位名称: Supervisor of Quality Control Support /QC支持组主管

• 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 Supervisor of Quality Control Support 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：

In General, responsible for QC quality system establishment and management, on-site inspection and feedback, instrument and facility establishment， maintenance and management，stability management, retention sample management, reference standard management, reagent and consumable management, training management, microbiological related method and specification management. Ensure QC quality system compliant and high efficient, supporting activities meet SOP requirement and testing needs. Responsible for continuous improvement and long-term capacity planning. Establish and maintain SMS mentality across unit; run SMS projects utilizing lean tools and methodologies.

职责概述：负责QC质量体系搭建和管理，现场审计及后续回复，仪器设备搭建维护管理，稳定性管理，留样管理，对照品管理，试剂耗材采购，培训管理，微生物相关方法和质量标准维护管理，确保QC质量体系合规高效，各项管理符合SOP要求及检验需求。负责QC的持续改善。建立和维护SMS思想，运用SMS工具和方法，执行SMS项目。

Specifically, 具体为

Ensure periodically reviewing QC quality system document and executing system document gap analysis. Use risk assessment to ensure QC quality system compliance and meeting business need. QC质量体系文件，及时执行体系文件差距分析，使用风险评估的方式确保QC质量体系合规的同时满足相关业务需求， Ensure QC instrument and facility compliance and meeting lab business need. QC仪器、硬件设施管理合规且符合实验室业务需求。 Ensure compliance of stability management, stability smart planning for meeting business. Ensure stability abnormal trend can be observed and reported in time. Ensure stability sample space capacity forecasting timely to meet business need.

Ensure compliance of retention sample management. Ensure retention sample space capacity forecasting timely to meet business need.
Ensure consumables reagent and reference standard management meeting testing group need. Ensure the management compliance with high efficiency.
Ensure training management compliance and meet lab business needs, Ensure QC management
Ensure microbiological analytical method and related specification gap analysis being executed timely and improved continuously.
Lead internal & External inspections for QC field and afterward actions. Supervise related CAPAs  being implemented in time. QC区域的内外部审计及后续的工作并执行或监督相关纠正预防措施的及时执行。 Lead QC long-term capacity planning and organize QC for continuous improvement based on it, Supervise CI quick-wins and projects progress. QC长期能力，并依此组织实验室人员持续改进监督CI quick-wins 和项目的进展。 Support or own related new Projects.
Review direct reports document.
Supervise the execution of 5S in the non-testing area. 5S执行。 Perform people performance management. Make individual develop plan with personnel within team and build up technical ladder.
QC senior supervisor HSE responsibilities QC高级主管HSE职责：

• Take direct management responsibility for direct reports HSE work and incorporate HSE work plan into the work plan.

对直属下级HSE工作负直接管理责任，将HSE工作计划纳入工作计划中。

• Organizing HSE training and education for those who have changed positions and those who have been re-appointed, and HSE education at the department level and post level for new employees;

组织对调换岗位人员、重新上岗人员进行HSE培训和教育，新员工进行部门级和岗位级HSE教育；

• Regularly carry out the investigation and management of HSE hidden dangers of the department, and keep records; implement the rectification of hidden dangers, and ensure that the experimental equipment, safety equipment, fire protection facilities, protective equipment and first-aid equipment are in good condition.

定期开展本部门HSE隐患排查治理工作，并做好记录；落实隐患整改，保证实验设备、安全设备、消防设施、防护用具和急救器具等处于完好状态。

• Report and deal with safety, environmental protection, and occupational health accidents in the laboratory in a timely manner, and insist that the cause of the accident is not clearly investigated, the employees are not educated, the responsible person is not dealt with, and the preventive measures are not spared. Implement the principle of "Four Do Not Let Go"; pay attention to protect the scene, find out the cause, distinguish the responsibility, implement the accident prevention measures and the handling opinions of the person responsible for the accident.

对实验室发生的安全、环保、职业健康事故及时报告和处理，要坚持事故原因调查不清不放过、职工不受到教育不放过、有关责任者未受处理不放过、防范措施未实施不放过的“四不放过”原则；注意保护现场，查清原因，分清责任，落实事故防范措施和对事故的责任者的处理意见。

• Participate in the daily +QDCI meeting to supervise whether the department +QDCI is carried out effectively.

参加每天+QDCI会议，监督本部门+QDCI是否有效开展。

• Organize various HSE activities, summarize and exchange HSE experience, and commend advanced teams and individuals.

组织各项HSE活动，总结交流HSE经验，表彰先进班组和个人。

Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.

赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展

•  Actively propose energy-saving projects

积极提出节能方案

•  Coordinate and support the development of energy-saving projects and give positive feedback

协调并支持节能项目的制定，积极反馈意见

• Coordinate and participate in the implementation of energy-saving projects

协调并参与节能项目的执行

• Participate in internal audit of energy management system

参与能源管理体系的内部评审

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: a minimum of 5 years’ experience in pharmaceutical industry management.

工作经验: 5年以上制药工业经验。

• Soft skill: Communication, problem solving oriented. as well as a good knowledge of Chinese and international GMP are required.

通用技能: 沟通，问题解决, 善于解决问题的能力和主动性。

• Technical skill: a good knowledge of Chinese and international GMP, DI are required.

专业技能: 要求熟悉中国和国际GMP，数据完整性要求。

• Education: related disciplines such as chemistry, pharmacy, biology, etc. bachelor degree at a minimum

教育背景: •化学、药学，生物等相关专业学士及以上学位

• Languages: Good at English writing, reading, listening and spoken

语言要求:英语听说读写良好

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!