M&S-Quality Excellence Manager-Beijing

Who we are?
As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.
Why start your career path in Sanofi?
Here, you can:

• Set clear direction & aligns team & others, around common objectives
• Inspire continuous improvement & breakthrough thinking,display analytical &conceptual thinking
• Have broad presence and resources within large platform to boarden globlal view sight
  

What you can contribute?

• To ensure effectiveness of site quality improvement programs/projects.
  

确保工厂运营的质量改进计划或项目的有效性

• Involve and supervise site quality improvement projects/programs (compliance program, QMI, DIMM etc) to ensure the effectiveness of project/programs.
  

参与并监管工厂质量改善项目或计划（如合规计划，质量成熟度评估，数据完整性成熟度评估等），以确保项目/计划的有效性。

• Involve in global quality audit and external inspection as site qualified coach for case rehearsal, auditee inspection skill coaching，complex case support etc.
  

作为工厂资质教练参与内外部审计， 演练审计问题, 辅导被审计人员审计技巧, 支持复杂问题迎审等。

• Conduct self-inspection as qualified lead auditor to ensure compliance level of site.
  

作为有资质的自检组长开展自检以确保工厂合规水平。

• Conduct audits as leader auditor to contractors/suppliers to assure they can supply product that meets established requirements.
  

作为有资质的检查组长开展供应商审计以保证合同方、供应商能提供符合要求的产品。

• Assure reliable batch release process to secure each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorization.
  

确保产品放行流程的可靠性以保证每一批产品的生产和检查符合相应国家的法规，并且符合上市许可的要求。

• Manage procedures to correct deviations and out of specification results and monitor the corrective and preventive actions (CAPA) to prevent the repetition of the not compliance instance.
  

有效管理偏差和OOS程序并监控整改和预防性整改措施的落实以预防不符合事件的重现

• Establish and assure a continuous GMP training to maintain an high level of GMP awareness in all the staff. 建立并持续开展GMP培训以维护全体员工高水准的GMP意识。
• Ensure a timely and effective communication and escalation to raise quality issues to the site quality head
  

确保及时有效的沟通和上报流以向工厂质量负责人上报质量问题

• Ensures quality risks are properly managed (identification, assessment, control, communication).
  

确保质量风险得到适当管理（识别、评估、控制和沟通）

• Assure the correct handling of product recall and customer complaints.
  

保证正确处理产品召回和客户投诉

• Ensure effectiveness of gap analysis process
  

保证差距分析流程的有效性

• 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.
  

负责贯彻公司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 plan
  

将HSE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.
  

组织实施本部门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.
  

定期开展本部门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.
  

负责部门级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.
  

积极配合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.
  

定期开展本部门各级+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.
  

参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。

• Responsible for design annual department PASS plan, and ensure implementation as planned.
  

负责制定年度部门PASS计划，并按进度组织实施。
What you should have?
Education / Experience
教育背景/经验
At least a bachelor or above degree in pharmacy or biology disciplines with minimum 10 years’ experience in quality area. Must be a committed "quality" professional with knowledge of quality systems within the pharmaceutical or related industry.
至少药学或生物学相关专业大学本科及以上学历，至少10年质量领域工作经验。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。
Technical Skills &
Competencies / Language
技能&能力/语言

• Thorough understanding of manufacturing processes and aseptic processes
  

全面理解生产流程和无菌工艺

• Strong working knowledge of quality systems, regulatory requirements across multiple health authorities， QP experience is preferred.
  

质量系统和各相关法规要求等方面具有工作经验, 有质量受权人经验者优先。

• Fluent English both in written and verbal
  

熟练的英语口语与书写能力

• Good communication skills
  

良好的 沟通能力

• Able to burden pressure
  

能够耐受压力

• Brave to make decision
  

果敢决策
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.