M&S-compliance supervisor质量合规主管-Beijing

Job title职位名称: Compliance Supervisor / 质量合规主管

• Grade级别: L2-1
• Location工作地点： Beijing
• % Remote working and % of travel expected 远程办公和出差的概率：≤10%
• Job type工作类型: Permanent长期
• Site/Unit 区域/事业部：Beijing site  北京工厂
• Solid Line Manager(Job Title and Name) ：

直线汇报上级（职位名称+姓名）： associate manager of quality system and compliance / Bob Bao

• Dotted Line Manager(Job Titel and Name):
• +姓名）：N/A
• Job description valid from:

修订时间：01/2025

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：

Responsible for Change Control process as business owner. Ensure all change control are recorded and managed in system.
Responsible for complaint process as business owner. Ensure all complaints (including PV and counterfeit cases) are handled properly.
Responsible for Site Self- Inspection and 3rd party audit and inspection readiness for external audits (HA inspection). Support related departments to execute the internal audits program, external audit.
Maintain all inspection readiness activities in an inspection ready status ahead of any internal or external audits.
Responsible for Recall process as business owner to ensure the process is complete, robust and effective. Lead and facilitate product recall when applicable.
Responsible for Quality Risk Management process as business owner to ensure quality risks are timely identified, assessed and controlled.  
Ensure all in-scope process compliant with applicable regulation and Sanofi requirement.
Participate in the investigation for accidents, analyze the root causes of accidents
Close monitor regulatory updating and lead site compliance continues improvement
Ensure to complete other tasks from line manager
Follow up validation related CAPA making sure they are completed on time.
Quality Department HSE Responsibilities质量部HSE职责 Responsible for following the company’s HSE policy, and integrated all requires into daily job. 彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。 Incorporate HSE work into the work planHSE工作纳入工作计划中。Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。Timely working out of employee opinions.HSE教育与考核工作；及时处理员工提出的意见。Actively cooperate with HSE management to prevent accidents happens.HSE管理工作，防止各类事故的发生。Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
Responsible for design annual department PASS plan, and ensure implementation as planned. PASS计划，并按进度组织实施。 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. “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: At least a bachelor degree in pharmacy or chemistry or biology disciplines with minimum 3 years management experience in production and /or quality assurance.

工作经验: 至少药学或化学或生物学或相关专业大学本科学历，至少3年生产或质量保证工作管理经验。

• Soft skill: Good communication and collaboration

通用技能: 良好的沟通与合作能力。

• Technical skill: Must be a committed "quality" professional with knowledge of regualed quality systems within the pharmaceutical or related industry.

专业技能: 必须具备制药或相关行业的质量体系的“质量”专业知识经验。

• Education: At least a bachelor degree in pharmacy or chemistry or biology disciplines

教育背景: 至少药学或化学或生物学或相关专业大学本科学历。

• Languages: Fluent English in verbal & written.

语言要求: 熟练的英语书写及沟通能力。

• 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