赛诺菲
Manufacturing and SupplyWhere the miracles of science are made a reality for patients
Manufacturing and SupplyWhere the miracles of science are made a reality for patients
发布于 大约 14 小时前中层管理(经理/总监)
深圳市
高级经验
全职员工
混合式弹性办公
学历未注明
医疗、制药与临床研究
团队领导
质量管理
监管法规
GMP
环境监测
微生物学
污染控制
无菌保证
无菌工艺模拟(Aps)
AI 估算 · 25k–40k
制药行业无菌保障负责人，要求5年经验，深圳大型外企，薪资具有竞争力，月薪在2.5-4万之间，年终奖通常1-2个月。
职位详情
关于这个职位
作为赛诺菲深圳工厂的无菌保障和微生物负责人，您将全面负责制定和实施无菌保证与微生物控制策略，确保疫苗生产符合GMP及监管要求
您将领导团队进行污染控制、环境监测、验证认证，并推动持续改进，是工厂质量体系的核心支柱
最低要求
years of experience in sterility assurance and microbiological control within a pharmaceutical or biotechnology environment
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)
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
Able to understand the design, procedural execution, and monitoring needed for low-bioburden or aseptic processes and to propose adequate Contamination Control Strategy
Analytical and problem-solving ability is important, along with knowledge of quality and technical regulations in a GMP environment
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
Language: Local language and English
工作职责
Developing and implementing comprehensive sterility assurance and microbiology 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 report 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 control 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
Interacting with external bodies & 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
Define the most appropriate methods and technologies for each product and process to ensure contamination control or sterility (D)
Provide technical expertise and support to other departments and functions on matters related to sterility assurance and microbiology (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)
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)
Provide trainings programs and strategies for SA competencies development and operator's qualification/requalification for SA systems (D)
履行领导交办的其他职责
AI 洞察
优缺点分析
优点
- 全球领先药企，平台大，体系完善，能接触先进的无菌保证技术和国际标准
- 岗位具有技术和管理双重属性，技能积累深厚，职业发展空间广阔
- 深圳工厂专注于疫苗生产，属于行业热点，社会价值高
- 需要频繁与内外部监管机构沟通，对沟通能力和抗压能力要求高
- 适合具有制药或生物技术背景，精通无菌保障和微生物学，具备较强质量意识和领导力，渴望在稳定平台中承担关键管理职责的专业人士
缺点 / 挑战
- 监管要求严格，工作压力大，对细节要求极高，需要持续学习和适应新法规
- 作为核心岗位，责任重大，任何失误可能导致产品质量问题，风险较高
角色解读
- 可向工厂质量负责人或区域无菌保证总监方向发展，承担更全面的质量管理职责
- 也可在集团内转向全球质量、合规或技术专家岗位，参与国际项目
- 积累经验后可成为行业咨询顾问或监管检查专家，拓展职业宽度
- 制定并执行无菌保证和微生物控制策略，确保疫苗生产符合GMP和监管要求
- 领导团队进行环境监测、污染控制、验证认证，推动持续改进项目
- 与生产、质量、数字等部门协作，监督生产活动，确保无菌保障体系稳健运行
- 深厚的无菌保证和微生物学专业知识，熟悉GMP、Annex 1、FDA指南等法规
- 具备污染控制策略制定能力，精通环境监测、无菌工艺模拟、验证认证
- 优秀的分析解决问题能力和领导力，能有效管理团队并与跨部门 stakeholders 沟通
申请策略
- 了解赛诺菲的'Take the Lead'价值观，在面试中展示与之契合的行为案例
- 强调对疫苗生产质量的高度责任感，以及推动持续改进的具体方法
- 重点突出5年以上无菌保证和微生物控制经验，列出具体项目成果（如降低污染率、通过审计等）
- 详细展示GMP、Annex 1、FDA指南等法规知识，以及实际应用案例
- 强调领导力和跨部门协作经验，包括团队管理、培训、外部审计参与等
- 补充最新无菌生产法规（如EU GMP Annex 1 2022修订版）和污染控制策略(CCS)知识
- 提升英语口语和书面表达能力，以满足外企工作中与全球团队沟通的需求
面试指南
- STAR法则：讲述情境(Situation)、任务(Task)、行动(Action)、结果(Result)，突出你的角色和量化成果
- 结构化回答：分点阐述法规依据、技术方案、执行步骤、风险管控和持续改进
- 体现领导力：强调团队合作、决策逻辑、向上管理和跨部门沟通
- 如何设计一个有效的污染控制策略(CCS)？请举例说明
- 描述一次你领导团队应对监管审计的经历，结果如何？
- 如何处理生产过程中出现的无菌偏差事件？你的纠正与预防措施(CAPA)思路是什么？
- 请解释无菌工艺模拟(APS)的关键要点和常见失败原因
- 你如何确保团队持续保持高质量意识和合规水平？
匹配度报告
79
综合匹配度
全球药企核心岗位，技术管理双发展，社会意义强，但地理位置偏远且WLB一般。
适合人群
适合追求职业使命感和行业发展，对工作地点偏远和一定工作强度有心理准备的求职者。
最强匹配
使命价值匹配
最弱匹配
工作生活匹配
薪资福利80
成长发展85
工作生活60
使命价值90
薪资福利匹配
80较高
职位薪资水平在深圳具备竞争力，外企福利完善，但未明确具体薪资和福利项，综合评分较高。
薪资信号未披露（AI估算：25K-40K/月）
成长发展匹配
85较高
岗位技术和管理双通道发展，可接触国际前沿的无菌保证技术，但JD中未明确提及晋升路径，评分较高。
技术前沿前沿/新兴技术
技术栈无菌保证、微生物学、GMP、污染控制策略、无菌工艺模拟
成长机会培训、能力发展
业务类型ambiguous
工作生活匹配
60中等
混合办公模式（20%远程），但工厂位于坪山区，位置偏远，且未提及弹性工时，WLB一般。
工作模式混合式弹性办公
办公地点郊区/偏远地区
加班情况未提及（无法判断）
使命价值匹配
90较高
疫苗生产直接关系公共卫生，岗位使命感和行业社会价值高，公司文化强调为患者行动。
行业发展高速增长赛道
社会影响正向社会影响力较高
使命信号为患者行动、照亮生命
创新程度积极采用新技术
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