M&S-Quality Risk Management Supervisor 质量风险管理主管-Beijing

Job title职位名称: Quality Risk Management Supervisor质量风险管理主管

• Location工作地点： Beijing

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 Quality Risk Management Supervisor 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：

Please indicate here the main job responsibilities请列举该职位的主要工作职责。

• Responsible for the management of quality risk to ensure the protection of patient, continuous improvement of quality system, process performance, product quality, regulatory and GxP compliance throughout the product life cycle.

负责质量风险管理，确保病人的安全、产品生命周期过程中质量体系的持续改进、过程绩效、产品质量、法规和GxP的合规性， 

• Contributes to the definition and continuous improvement of the quality system. Provides expertise and support for the implementation of the quality systems.
• Ensure the cGMP compliance of Beijing Site.
• cGMP规定；
• Responsible for the management of quality risk to ensure the protection of patient, continuous improvement of quality system, process performance, product quality, regulatory and GxP compliance throughout the product life cycle, including update and maintenance of QRM procedure and QRM master plan to make QRM principle and practices integrated into the quality management system, leading QRM related project to construct the SQRP frame, etc.
• GxP的合规性， 包括更新和维护质量风险管理的流程和风险管理主计划，推动质量风险管理的原则和实践在质量体系各因素中的应用，负责质量风险管理相关的项目和工厂质量风险档案的框架建立。
• Work with the Process Owners to identify a Facilitator for all Formal Risk Assessments. Maintain Quality Site Risk Profile (SQRP).  Communicate risks to appropriate stakeholders in site level.
• SQRP）；负责与工厂内部利益相关者的风险沟通。
• Responsible for QRM related training in site, including procedures, risk assessment tools and others.
• Responsible for initiation of risk event in system, coordinating event investigation and risk level assessment, as well as communication with global QAM team according to Sanofi’s requirement. Escalation of Quality Event and Management of Quality Alert.
• Responsible for the organization and coordination of recall and mock recall.
• Responsible for organization site Quality Maturity Index (QMI) assessment and maintenance QMI assessment result.
• QMI）评估并维护QMI评估结果。
• Organize and manage the Gap analysis of site local procedure documents with global quality document.
• Responsible for deviation and complaint system process to ensure the system in compliance with regulation and Sanofi global requirements
• 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.
• HSE Responsibilities of the Quality Department质量部HSE职责

Incorporate HSE work into the work plan.

Actively cooperate with HSE management work to prevent the occurrence of various accidents.

Regularly hold+QDCI meetings at all levels of the department, in conjunction with HSE8 requirements, promptly and correctly fill in and provide feedback on various HSE issues, and actively implement rectification measures.

Participate in accident investigation and analysis work, analyze the causes of accidents from the perspective of quality management, and propose accident prevention measures.

• HSE工作纳入工作计划中。
• HSE管理工作，防止各类事故的发生。
• +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。

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 5 years related experience in quality control and /or quality assurance in pharmaceutical industry ore relevant area, people management experience is preferred.
• 5年以上制药行业质量控制或质量保证相关工作经验，有管理经验优先
• Soft skill: Good communication skill,
• Technical skill: Must be a committed "Quality" professional with knowledge of regulated quality systems within the pharmaceutical or related industry. Knowledge of Chinese pharmaceutical rules is mandatory as well as basic knowledge of international GMP’s. Knowledge of Chinese pharmaceutical rules is mandatory as well as basic knowledge of international GMP’s.
• : 具备药学或相关工业领域质量系统相关专业知识。须具有中国药品管理知识及国际GMP的基本知识。具有中国药品管理知识及国际GMP的基本知识。
• Education: A bachelor degree in pharmacy or similar disciplines.

教育背景: 药学或相关专业本科。

• Languages: Good command of written and spoken English.

语言要求: 具备良好的英语书写和表达水平。

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!