M&S-Senior Supervisor of Quality System & Compliance-Hangzhou

Job title职位名称: Senior Supervisor of Quality System& Compliance质量体系高级主管

• Location工作地点: Hangzhou Site 杭州工厂

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 Senior Supervisor of Quality System& Compliance within our M&S China-HGZ 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。

General Mission职责概述

• Ensure Hangzhou Site (HZG) operation complying with Chinese, EU GMP and related regulations, and the quality requirement of Sanofi Group
  确保杭州工厂运营符合中国,欧盟相关法规'以及赛诺菲集团质量要求。
• Ensure the quality system executing effectively, Quality KPI is maintained within target.
  确保质量系统在工厂有效运行'相关质量指标维护在目标之内。
• Ensure self-inspection system is carried out effectively, external inspection was prepared and supported well.
  确保内部审计有效的执行'外部审计得到良好的准备和支持。

Activities具体职责

• Be responsible for creating and maintaining the system of Data Integrity, ensure execute effectively in the site.
  负责建立维护工厂内数据完整性体系'确保工厂按照数据完整性要求有效的运行
• Be responsible for creating and maintaining documentation management system, ensure site documents and records are manged properly based on Sanofi requirement, the E-operating system of document is applied effectively in the site as the Business Owner.
  负责建立和维护工厂文件管理体系'确保工厂的文件/记录按照赛诺菲要求有效执行。作为文件管理系统的负责人'确保文件管理系统在工厂内有效运行。.
• Be responsible for creating and maintaining training management system, ensure site training is carried out based on Sanofi requirement, the E-operating system of training is applied effectively in the site as the Business Owner, and the training is completed on time.
  负责建立和维护工厂培训管理体系'确保工厂的培训按照赛诺菲要求有效执行。作为培训管理系统的负责人'确保培训管理系统在工厂内有效运行'相关培训能按时完成。
• Be responsible for creating and maintaining Deviation and CAPA management system, ensure site Deviation and CAPA is handled properly based on Sanofi requirement, the E-operating system of training is applied effectively in the site as the Business Owner, and the task in each phase is completed on time.
  负责建立和维护工厂偏差/纠正预防措施管理体系'确保工厂的偏差/纠正预防措施按照赛诺菲要求有效执行。作为偏差/纠正预防措施管理系统的负责人'确保偏差/纠正预防措施管理系统在工厂内有效运行'并各个阶段的任务均能按时完成。
• Be responsible for creating and maintaining Change Control management system, ensure site Change Control is managed properly based on Sanofi requirement, the E-operating system of Change Control is applied effectively in the site as the Business Owner, and the task in each phase is completed on time.
  负责建立和维护工厂变更控制管理体系'确保工厂的变更控制按照赛诺菲要求有效执行。作为变更控制管理系统的负责人'确保变更控制管理系统在工厂内有效运行'各个阶段的任务均能按时完成。
• Be responsible for creating and maintaining Quality Complaint management system, ensure Quality Complaint is handled properly based on Sanofi requirement, the E-operating system of Quality Complaint is applied effectively in the site as the Business Owner, and the task in each phase is completed on time.
  负责建立和维护工厂质量投诉管理体系'确保工厂的质量投诉按照赛诺菲要求适当的处理。作为质量投诉管理系统的负责人'确保质量投诉管理系统在工厂内有效运行'各个阶段的任务均能按时完成。
• Be responsible for creating and maintaining Qualification and Validation management system, oversight the qualification and validation activity in site from QA perspective, to ensure all activities complying with Sanofi requirement.
  负责建立和维护工厂内确认和验证管理体系'从质量保证的角度监督工厂确认和验证体系有效运行'确保符合赛诺菲关于确认和验证的要求。
• Be responsible for creating and maintaining 3rd Party Quality management system, ensure 3rd Party is evaluated and approved properly based on Sanofi requirement, oversight of 3rd party quality.
  负责建立和维护供应商质量管理体系'确保供应商按照赛诺菲要求进行了质量评估和审批'监督供应商质量绩效。
• Be responsible for creating and maintaining self-inspection system, ensure self-inspection is carried out in the site based on Sanofi requirement, and the output is followed up and completed on time.
  负责建立和维护工厂自检体系'确保自检内按照赛诺菲要求在工厂内有效执行'自检输出能有效跟踪并按时完成。
• Be responsible for organize and prepare the external inspection, ensure the inspection readiness, inspection on-site management, and the output is followed up and completed on time.
  负责组织,准备外部检查'确保检查得到良好的准备'检查过程中有序推进'检查输出得到良好的跟踪并按时关闭。
• Be responsible for creating and maintaining Risk management system, ensure the risk management carrying out in the site based on Sanofi requirement.
  负责工厂质量风险管理体系的建立和维护'确保符合工厂按照赛诺菲要求进行风险管理。
• Be responsible for creating and maintaining of quality alert and product recall, ensure product quality alert and recall/mock recall executing based on Sanofi requirement.
  负责工厂建立和维护产品质量警报和产品召回系统'确保产品质量警报'产品召回/模拟找回符合赛诺菲要求。
• Be responsible for the team management of Quality system, ensure team carrys out the work efficiently, and the talent is developed based on IDP.
• 负责质量体系团队管理'确保团队高效的开展工作'人员基于人员发展计划有序发展。

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 10 years quality assurance in pharmaceutical company
  工作经验: 至少10年以上制药行业的质量管理工作
• Soft skill: Master to cGMP and regulation, Familiar to office software, Good communication and transversally cooperation, team leading
  通用技能:精通现行GMP和法规'熟练应用办公电脑软件'良好的沟通协调能力'团队领导力。
• Technical skill: Familiar to EU & United state GMP, ICH regulation, ISO quality management system。
  专业技能: 熟悉欧美GMP'ICH等法规及ISO质量管理体系。
• Education: bachelor's degree above, Pharmacy or related field
  教育背景: 本科学位以上'药学或相关专业。
• Languages: Good at English reading, writing, listening and speaking'be able to discuss the topics of quality and compliance in English fluently.
  语言要求: 良好的英语听,说,读,写能力'可以流畅的用英语探讨质量和合规相关的话题。

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.

Pursue Progress. 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!