M&S-LIMS Project Leader-Hangzhou

Job title职位名称: LIMS Project Leader

• 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 Supervisor of QC Excellence & Project /QC 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

• Coordinate related stakeholder according to the site’s project master plan to ensure that the site’s LIMS system is deployed according to Sanofi’s system, ensuring compliance with quality, documentation and GMP and environmental/safety/health requirements
• LIMS系统按赛诺菲的体系部署，确保符合质量、文件记录和GMP以及环境/安全/健康的要求。
• Use digital tools to lead the optimization of laboratory processes and methods, improve laboratory regulatory compliance and test efficiency
• Assure all test perform according plan， assure all of instrument can support testing work,  assure all the analyses are carried out in compliance with analytical methods. Assure quality, Good Documentation Practices, cGMP, safety health and environmental standards are met.
• GMP以及环境/安全/健康的要求。
• Drafts standard operating procedures, analytical methods and instrumental validation/verification protocols, Assure the validation/verification carried out correctly.
• Training and support analyst in LIMS operation field

对检验员在LIMS操作领域的工作给予培训和支持

Activities具体职责

• Organize project team members to complete the deployment of LIMS projects according to the site plan.
• LIMS项目的部署。
• Ensures that the LIMS project architecture process for deployment meets the quality and digital requirements of Sanofi Group.
• LIMS项目架构流程符合赛诺菲集团的质量和数字化要求。
• Ensure that the LIMS project deployed meets the requirements of local regulations and GMP.
• LIMS项目符合当地法规和GMP的要求。
• Ensure that the LIMS project deployed can lead the quality control schedule and capacity planning to support the timely release of products and the adherence of the test’s execution to the committed standard times.
• LIMS项目能领导质量控制计划和产能规划，以支持及时释放产品并遵守承诺的标准时间执行测试。
• Ensure that the LIMS project deployed can define and maintaining the maintenance, qualification and calibration plans to ensure valid status of the lab equipment.
• LIMS项目能定义和维护维修、确认和校准计划，以确保实验室设备的有效状态。
• Ensure that the LIMS project deployed can handle sample management flows from sampling to receiving and dispatching to the appropriate labs (including stability and EM sample management per plan).
• LIMS项目能处理从取样到接收和发送到适当实验室的样品管理流程（包括按计划进行稳定性和 EM 样品管理）。
• Ensure that the LIMS project deployed can manage reference standards and reagents for the labs.
• LIMS项目能管理实验室的对照品和试剂。
• Implementation and maintenance of QC digital solution (core model and local) (including data management and end-user management).
• QC 数字解决方案（核心模型和本地）（包括数据管理和最终用户管理）。
• Managing and training QC project team.
• QC 项目团队。
• HSE management is under the responsibility of the line Manager, he/she will provide a safe working environment for the employees. 

• Allocate appropriate and sufficient human, financial and material resources to ensure effective implementation of HSE programs (such as HSE event investigation, risk assessment identification and control, training, inspection, HSE action plan, leading safety program, PPE, HSE CAPAs follow up …… ) and management of all HSE issues.
  • HSE工作(比如HSE事件调查、风险识别和管控、培训、HSE工作计划、领先安全管理、PPE，HSE整改跟进……)得到有效实施和HSE问题得到有效解决。

• Other works assigned by QC manager.

上级安排的其他工作。

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 QC analysis and 3 year management working experience。 Multi-national Company experience preferred。制药行业QC至少5年分析工作及3年管理工作经验。有跨国制药行业经验优先。
• Familiar to LIMS projects and proficiency in digital technology.

熟悉LIMS，熟练运用数字化技术。

• Experience in Project management。具有项目管理经验。
• Soft skill: Familiar to cGMP and regulation, Familiar to office software, Good communication and transversally cooperation, team leading
  通用技能：熟悉现行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 CHP,EU & United state GMP, ICH regulation。
  专业技能: 熟悉中欧美药典，GMP，ICH等法规。
• Education: Bachelor’s degree above, Pharmacy or Chemical related field.
  教育背景: 本科学位以上，药学或化学相关专业。
• Languages: Good at English reading, writing, listening and speaking，be able to discuss the topics of quality and testing 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检验相关的话题。
• 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

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!