Job Information职位信息

Job title职位名称: Quality Sterility Assurance & Microbiology Lead 无菌保障和微生物负责人

• Location工作地点： Shenzhen, China 中国深圳
• % Remote working and % of travel expected 远程办公和出差的概率：20%
• Job type工作类型: Full time全职
• Site/Unit 区域/事业部：Beijing Site/ M&S China北京工厂/中国制造与供应事业部 

About the job工作职责

Our Team我们的团队：
The Manufacturing & Supply Division comprises a manufacturing platform based on three global business units, along with support departments such as Quality, Suppliers, and Lean Strategy. It is dedicated to using superior strategies and tools to manufacture high-quality medicines and deliver them to patients.

About our team: Sanofi, a leading global innovative pharmaceutical and healthcare company, focuses its Shenzhen plant on the entire process of influenza vaccine manufacturing and local packaging of imported vaccines, serving the Chinese market. The plant is located at Sanofi Life Science Park, No. 25 Jinxiu East Road, Pingshan District, Shenzhen.

Aseptic assurance personnel, upholding Sanofi's "Take the Lead" values, are a core pillar of plant contamination control:

Aim Higher - We focus on our most important quality objectives, setting high standards and driving our work with a sense of urgency, learning from setbacks to achieve higher performance.

Act for Patients - We never compromise on integrity, removing barriers and collaborating with others to get patients going faster and further.

Be Bold - We take thoughtful risks, seize opportunities, and push the boundaries of possibility to accelerate our scientific progress.

Lead Together - We build trust, collaborate openly around shared goals, celebrate collective victories, and foster a sense of belonging.
We are committed to operational excellence in aseptic assurance, ensuring its continued robust operation through core functions such as contamination control, fulfilling our mission of "Seeking scientific miracles to illuminate life."

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。

赛诺菲作为一家全球领先的创新医药健康企业，深圳工厂专注于流感疫苗的全流程生产制造及进口疫苗的本地包装，服务于中国市场。工厂位于深圳市坪山区锦绣东路25号赛诺菲生命科学园区。
无菌保障人员秉承赛诺菲"Take the Lead"价值观，是工厂污染控制的核心支柱：
Aim Higher - 我们专注于最重要的质量目标，设定高标准并以紧迫感推进工作，从挫折中学习以实现更高绩效
Act for Patients - 我们绝不在诚信上妥协，消除障碍并与他人合作，为患者走得更快更远
Be Bold - 我们承担深思熟虑的风险，抓住机遇，超越可能的边界来加速我们的科学进步
Lead Together - 我们建立信任，围绕共同目标开放合作，庆祝集体胜利并培养归属感
我们致力于无菌保障的卓越运营，通过污染控制等核心职能，确保无菌保障持续稳健运行，践行"追寻科学奇迹，焕发生命光彩"的使命。

Main responsibilities职责描述：
•    Developing and implementing comprehensive sterility assurance and microbiology programs in alignment with the organizational strategy, vision, and objectives 根据组织战略、愿景和目标，制定和实施全面的无菌保证和微生物学计划 
•     Developing and implementing effective strategies and procedures for sterility assurance and microbiology across the organization (environment, water, steam, gas, bio-cleaning, gowning, aseptic processes and practices and industrial supplies, etc.) and Qualification/Validation for processes (microbio strategy) 制定并实施有效的战略和程序，确保整个组织无菌和微生物学（环境、水、蒸汽、气体、生物清洁、穿衣、无菌流程和实践以及工业用品等），以及流程认证/验证（微生物战略）
•    Ensuring the compliance of products and processes with applicable sterility assurance and microbiology regulatory requirements and company quality standards 确保产品和流程符合适用的无菌保证和微生物监管要求以及公司质量标准 
•    Maintaining a system to ensure sterility assurance and microbiological risks are properly identified, tracked and mitigated  维护系统，确保正确识别、跟踪和缓解无菌保证和微生物风险  
•    Overseeing of production activities as (MFT, best aseptic practices ....)  监督生产活动（MFT，最佳无菌实践......）  
•    Overseeing, with Q&V team, the validation, qualification and monitoring of methods, equipment and the environment ensuring sterility assurance control  与 Q&V 团队一起监督方法、设备和环境的验证、确认和监控，确保无菌保证控制  
•    Following metrics and monitoring data for the sterility assurance and microbiological activities, to identify trends and issues and to implement action plan  遵循无菌保证和微生物活动的指标和监测数据，以确定趋势和问题，并实施行动计划  
•    Establishing and monitoring key performance indicators (KPIs) and metrics for the sterility assurance and microbiological activities, and report on its performance and effectiveness  建立和监控无菌保证和微生物活动的关键性能指标（KPI）和指标，并报告其性能和有效性  
•    Promoting a culture of quality throughout the organization  在整个组织内推广质量文化  
•    Identifying and driving continuous improvement initiatives and projects to enhance the sterility assurance and microbiological control activities  确定并推动持续改进计划和项目，以加强无菌保证和微生物控制活动  
•    Evaluating and recommending new technologies, tools, and methods to enhance sterility assurance and microbiology  评估和推荐新技术、工具和方法，以增强无菌保证和微生物学  
•    Leading management reviews to assess the effectiveness of the sterility assurance program and microbiological program  领导管理层审核，以评估无菌保证计划和微生物计划的有效性  
•    Interacting with external bodies & Global Quality to bring knowledge and awareness of best industry practices (Congress, CoP and CoE)  与外部机构和全球质量部门互动，以提升对最佳行业实践（Congress、CoP 和 CoE）的知识和认识  
•    Preparing and participating in regulatory inspections and audits, providing expertise on sterility assurance and microbiology  准备并参与监管检查和审计，提供无菌保证和微生物学方面的专业知识  
•    Providing support for the successful collaboration between Digital, Quality, and technical functions to achieve desired functionality, compliance, and productivity for new solutions in Sterility Assurance and Environmental Monitoring areas  为数字、质量和技术职能部门之间的成功合作提供支持，以实现无菌保证和环境监控领域新解决方案所需的功能、合规性和生产力

关键角色（决定/D，A，分享/I）
•    Define the most appropriate methods and technologies for each product and process to ensure contamination control or sterility (D)  为每个产品和流程定义最合适的方法和技术，以确保污染控制或无菌（D）  
•    Provide technical expertise and support to other departments and functions on matters related to sterility assurance and microbiology (A)  就无菌保证和微生物学相关事宜，向其他部门和职能部门提供技术专业知识和支持（A）  
•    Lead most critical SA and microbiological events and define the corrective and preventive actions to be taken in response to any non-conformities or deviations related to sterility assurance and microbiology (A) 领导最关键的 SA 和微生物事件，并定义应对与无菌保证和微生物学相关的任何不符合项或偏差而采取的纠正和预防措施（A）  
•    Ensure with the team a regular presence (25% of time) on the shopfloor with operational teams to carry out oversight, coach and develop knowledge (A)  确保团队定期（25% 的时间）在车间与运营团队一起监督、指导和发展知识（A）  
•    Provide trainings programs and strategies for SA competencies development and operator's qualification/requalification for SA systems (D)  为 SA 能力发展和 SA 系统操作员资格/再资格鉴定提供培训计划和策略（D）
其他职责
•    履行领导交办的其他职责
•    Perform other duties assigned by leader

About you 任职资格:
预期经验
Expected Experience
•    5 years of experience in sterility assurance and microbiological control within a pharmaceutical or biotechnology environment  5 年制药或生物技术环境无菌保证和微生物控制经验

预期的技术技能
Expected Technical skills
•    Strong Quality mindset with experience in managing compliance and Health Authority regulations. In-depth knowledge of regulatory requirements and Good Manufacturing Practices (Annex 1, FDA guidance, Pharmacopeia)  具有强大的质量思维，在管理合规和卫生监管部门法规方面拥有丰富的经验。深入了解监管要求和良好生产规范（附录 1，FDA 指南，药典）  
•    Expertise and understanding of technical aspects of low bioburden and/or sterile manufacturing (including aseptic processes, aseptic process simulation (APS) when applicable), microbiological testing and environmental monitoring  对低生物负荷和/或无菌生产（包括无菌工艺、适用时的无菌工艺模拟（APS））、微生物检测和环境监测的技术方面的专业知识和理解  
•    Able to understand the design, procedural execution, and monitoring needed for low-bioburden or aseptic processes and to propose adequate Contamination Control Strategy  能够了解低生物负载或无菌工艺所需的设计、程序执行和监测，并提出充分的污染控制策略  
•    Analytical and problem-solving ability is important, along with knowledge of quality and technical regulations in a GMP environment  分析和解决问题的能力很重要，同时了解 GMP 环境中的质量和技术法规  
•    Ability to establish and maintain strong and effective working relationships with key stakeholders on site, and collaboration across the site is essential, requiring excellent written and verbal communication and presentation skills  能够与现场的主要利益相关者建立并保持牢固有效的工作关系，并且整个现场的协作至关重要，需要出色的书面和口头沟通和演示技能

Language 语言
•    当地语言和英语
•    Local language and English

Pursue progress, discover extraordinary进无止境，探索菲凡

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people. 
At Sanofi, we provide equal opportunities to all regardless of race, colour, 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! 
进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。
在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。
观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。
Take The Lead Behaviours：Aim Higher、Act for Patients、Be Bold and Lead Together
引领前行行为：更高目标、以患者为本、勇于创新、共同领导

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!