赛诺菲
M&S-Sterility Assurance Lead-Beijing
M&S-Sterility Assurance Lead-Beijing
发布于 2 小时前中层管理(经理/总监)
全职员工仅现场办公制药生产运营
制药生产运营
Capa
Cgmp
Team Leadership
值不值得投
81综合评分
综合评分 81
高社会价值、强专业壁垒的跨国药企中层管理岗，福利完善，侧重无菌质量保证与团队领导
从薪资福利、成长发展、工作生活和使命价值四个维度综合评估，方便横向比较。
薪资怎么样
参考估算薪资
根据职位描述推断，供对比参考
发布情况
新岗位 · 今天发布
公司情况
这家公司招聘很活跃
约 170 个在招
职位详情
关于这个职位
作为赛诺菲北京工厂的无菌保证负责人，你将全面领导无菌保证与微生物团队，制定并实施无菌策略、污染控制策略（CCS）及环境监测计划
你需要确保生产全流程符合cGMP及药典要求，主导验证、审计应对及持续改进项目，通过技术领导力保障生物制剂的无菌安全与合规性
最低要求
领导和管理无菌保证和微生物学团队，包括招聘、培训、辅导、职业发展和绩效评估
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
确保环境监测相关的日常工作遵循GMP的要求得以执行并满足业务需求
准备和开发相关质量标准和分析检验方法
负责环境监测及无菌保证相关的项目及持续改善，验证及调查工作
支持污染控制策略的实施及无菌产品生产防止污染，并解决环境监控，公用工程，工艺设备，物料，产品检测，以及生产车间的相关验证中的微生物污染或无菌检验结果的异常
执行EM，CCS，更衣相关总部要求及本地法规标准的差距分析，并且实施纠正预防措施
在各种审计过程中作为无菌保障专家参与审计问题的回答
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
工作职责
Developing and implementing comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives
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)
Ensuring the compliance of products and processes with applicable sterility assurance and microbiology regulatory requirements and company quality standards
Maintaining a system to ensure sterility assurance and microbiological risks are properly identified, tracked and mitigated
Overseeing of production activities as (MFT, best aseptic practices ....)
Overseeing, with Q&V team, the validation, qualification, and monitoring of methods, equipment, and the environment ensuring sterility assurance control
Following metrics and monitoring data for the sterility assurance and microbiological activities to identify trends and issues and to implement action plan
Establishing and monitoring key performance indicators (KPIs) and metrics for the sterility assurance and microbiological activities and reporting on its performance and effectiveness
Promoting a culture of quality throughout the organization
Identifying and driving continuous improvement initiatives and projects to enhance the sterility assurance and microbiological activities
Evaluating and recommending new technologies, tools, and methods to enhance sterility assurance and microbiology
Leading management reviews to assess the effectiveness of the sterility assurance program and microbiological program
Leading and managing the sterility assurance and microbiology team, including hiring, training, coaching, professional development, and performance evaluation
Interacting with external bodies and Global Quality to bring knowledge and awareness of best industry practices (Congress, CoP and CoE)
Preparing and participating in regulatory inspections and audits, providing expertise on sterility assurance and microbiology
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
To ensure the operations in environmental monitoring fulfill the GMP requirement. Prepare the relevant specifications and analytical test methods to ensure the routine monitoring of the manufacturing area is correctly performed.
Be responsible to projects and continuously improvement, validation and investigation in EM and sterile assurance
Support in implementation of contamination control strategy (CCS) and sterile product manufacturing to prevent contamination, and contribute to the trouble shooting for sterility/microbe contamination issue in EM, equipment, utility, material, product and production related validation etc.
Developing or assisting the develop microbial/EM assessment SOP to support routine operation, e.g. EM and utility monitoring and testing.
Ensure that monitoring is carried out in compliance with specifications, Pharmacopeia requirements and the cGMP and analyse the trend of the analytical results. Ensure the exceeding limit investigation is conducted properly.
Keep close relationship and communication with other departments to ensure proper execution of the production plan.
Implement GAP analysis for global requirement and local authority standard and take CAPA actions related to EM，CCS and gowning.
Support in clean zone re-construction, process optimization, people’s awareness enhancement, utility control from contamination control and microorganism monitoring perspective.
Participate in the investigation for sterility/microbe contamination issue in EM, equipment, utility, material, product, APS etc.
Support in implementation of the CCS (contamination control strategy).
Support in technical training deployment in site level regarding to the contamination control.
As SA role, participate in the expert assessment regarding contamination control related change control.
Participate in related inspection, to answer auditor’s questions as Sterility Assurance SME, and corporate with such as production and engineering department to answer SA related questions.
Responsible for following the company’s HSE policy and integrated all requires into daily work. Incorporate HSE work into the work plan
Participate the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.
Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.
Timely working out of employee opinions.
Actively cooperate with HSE management to prevent accidents happens.
Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.
Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
AI 洞察
优缺点分析
优点
- 依托赛诺菲全球领先的制药平台，接触最前沿的无菌技术和国际标准
- 职位具有高度的专业权威性和影响力，直接关乎患者生命安全
- 完善的福利体系和清晰的晋升通道，有利于长期职业发展
- 对团队管理和跨部门协作能力要求极高
- 拥有深厚制药行业背景、具备丰富无菌保证经验和团队管理能力的资深专业人士
- 追求高职业稳定性、注重工作社会价值且能承受高压合规要求的求职者
缺点 / 挑战
- 作为关键合规岗位，面临严格的监管压力，需确保持续零缺陷
- 需要平衡生产进度与质量合规之间的关系，处理突发偏差和审计挑战的工作强度较大
角色解读
- 可向更高层级的质量管理总监（Quality Director）、制造与供应副总裁（VP of M&S）发展，或在集团内转向全球质量战略、合规事务等高级管理职位
- 也可成为行业内的无菌保证领域顶级专家顾问
- 全面负责北京工厂无菌保证（SA）和微生物实验室的战略规划与日常运营，建立并优化无菌策略和污染控制策略（CCS）
- 领导团队进行环境监测、数据趋势分析及偏差调查，确保生产过程符合cGMP和药典标准
- 作为内部专家，主导应对国内外监管机构的审计与检查
- 精通无菌保证原理、微生物学及污染控制策略（CCS）
- 熟练掌握cGMP、FDA/EMA/NMPA相关法规及审计流程
- 具备强大的团队管理能力、跨部门沟通协调能力及问题解决能力（CAPA）
申请策略
- 了解赛诺菲在北京工厂的具体产品线（如疫苗、单抗等）及其对应的无菌工艺特点
- 在面试中展现对‘质量源于设计’（QbD）理念的深刻理解，以及如何将质量文化融入日常运营的见解
- 突出展示在无菌保证、污染控制策略（CCS）制定与实施方面的成功案例
- 强调主导过成功的FDA/EMA/NMPA审计经验及零严重缺陷记录
- 列举团队规模、管理幅度及推动的重大持续改进项目（如降本增效、技术升级）
- 深入研究最新的ICH指南及各国药典关于无菌生产的最新要求
- 提升数据分析能力，利用统计工具进行环境监测数据的趋势分析
- 强化领导力技巧，特别是在变革管理和跨文化团队管理方面的能力
面试指南
- 采用STAR法则（情境、任务、行动、结果）结构化回答
- 重点展示逻辑思维能力、法规依据引用准确性、危机处理能力以及以数据和事实为基础的决策过程
- 强调‘患者安全第一’的核心价值观
- 请分享一个你成功实施污染控制策略（CCS）的案例，你是如何识别风险并制定缓解措施的？
- 在面对监管机构（如NMPA或FDA）的突击审计时，你如何协调团队并确保顺利通过？
- 当生产进度与质量合规发生冲突时，你如何做出决策并处理相关利益方？
- 你如何评估和提升团队的技术能力及质量意识？
- 复习最新的cGMP无菌附录及ISO 14644等相关标准
职位点评
薪资福利85
成长发展80
工作生活70
使命价值90
薪资福利
85较高
赛诺菲作为已上市的跨国巨头，提供具有市场竞争力的薪酬包及全面的福利体系（如补充医疗、带薪休假等），对补偿性动机满足程度较高。
薪资信号未披露（AI估算：4.5千–7.5万/月）
福利待遇healthcare、wellness programs、gender-neutral parental leave、rewards package
成长发展
80较高
职位涉及前沿的无菌保证技术与污染控制策略，且公司提供全球范围内的职业发展空间和培训资源，有利于专业技能与管理能力的双重提升。
技术前沿主流现代技术
技术栈Sterility Assurance、Contamination Control Strategy (CCS)、Environmental Monitoring、Validation、cGMP
成长机会grow your career、promotion or lateral move、professional development、technical training deployment
业务类型cost_center
工作生活
70中等
跨国药企通常提供较好的工作生活平衡支持（如性别中立陪产假），但作为生产端的关键管理岗，需应对审计和生产波动，可能面临一定的现场工作压力。
工作模式仅现场办公
办公地点科技园/产业园
加班情况未提及（无法判断）
工作生活平衡gender-neutral parental leave、wellness programs
使命价值
90较高
职位直接关联‘保护患者免受传染病侵害’和‘改善人们生命’的使命，社会价值感极强，对意义感动机有极高的满足度。
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号protect people from infectious diseases、bring hope to patients、improve people’s lives、make miracles happen
创新程度积极采用新技术
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