Job Information 职位信息
Job title职位名称: QA Ops & Batch Release Lead
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：N/A
- 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：
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。
关于我们的团队：
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。
我们的质量运营（QA Ops）与PCU团队秉承赛诺菲"Take the Lead"价值观，是工厂质量与卓越运营的核心支柱：
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
团队致力于质量管理的卓越运营，通过放行管理、产品质量回顾（PQR）及生产质量运营等核心职能，确保质量体系持续稳健运行，践行"追寻科学奇迹，焕发生命光彩"的使命。
The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools.
About Our Team:
As a globally leading innovative biopharmaceutical company, Sanofi's Shenzhen site focuses on the end-to-end manufacturing of influenza vaccines and local packaging of imported vaccines, serving the Chinese market. The site is located at Sanofi Life Sciences Park, No. 25 Jinxiu East Road, Pingshan District, Shenzhen.
Our Quality Operations (QA Ops) and PCU team upholds Sanofi's "Take the Lead" values and serves as a core pillar of quality and operational excellence at the site:
- Aim Higher – We focus on the most critical quality objectives, set high standards, and drive our work with a sense of urgency, learning from setbacks to achieve higher performance.
- Act for Patients – We never compromise on integrity, remove obstacles, and collaborate with others to go further and faster for patients.
- Be Bold – We take calculated risks, seize opportunities, and push beyond the boundaries of what is possible to accelerate our scientific Progress.
- Lead Together – We build trust, collaborate openly around shared goals, celebrate collective wins, and foster a sense of belonging.
The team is committed to excellence in quality management. Through core functions including release management, Product Quality Review (PQR), and manufacturing quality operations, we ensure the continuous and robust operation of the quality system — living out the mission of "Chasing the miracles of science to improve people's lives."
Main responsibilities 职责描述：
- 确保其范围内的活动按照适用的监管要求进行
- Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
- 确保符合药品生产质量管理规范 （GMP） 和其他相关法规
- Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
- 对生产流程进行定期审计，以识别和解决潜在的质量问题
- Conducting regular audits of production processes to identify and address potential quality issues
- 与生产部门密切协作，确保在整个产品生命周期内保持质量标准；强����建议位于车间
- Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
- 及时有效地管理和解决质量相关问题
- Managing and resolving quality-related issues in a timely and effective manner
- 监控和分析质量绩效指标，根据需要实施纠正措施
- Monitoring and analyzing quality performance metrics, implementing corrective actions as needed
- 领导质量事故的根本原因分析调查并实施预防措施
- Leading root cause analysis investigations for quality incidents and implementing preventive measures
- 参与内部和外部审计和监管检查，提供支持和文件
- Participating in internal and external audits and regulatory inspections providing support and documentation
- 制定和实施风险管理策略，以缓解潜在的质量问题
- Developing and implementing risk management strategies to mitigate potential quality issues
- 在整个组织内培养质量和持续改进的文化
- Fostering a culture of quality and continuous improvement across the organization
- 监督批次放行流程，确保符合监管要求和公司标准
- Overseeing the batch release process to ensure compliance with regulatory requirements and company standards
- 监督批记录和相关文件的审核和批准
- Overseeing review and approval of batch records and associated documentation
- 确保所有批次放行活动符合药品生产质量管理规范 （GMP）
- Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
- 进行风险评估并实施批次放行流程的缓解策略
- Conducting risk assessments and implementing mitigation strategies for batch release processes
- 参与跨团队（质量控制、生产）的行动协调，以确保按照流量控制器的优先级及时放行批次
- Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities
- 调查和解决与批次放行相关的任何问题或偏差（包括如果分销渠道面临异常事件，则评估每个产品的温度偏差）
- Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)
- 参与内部和外部审计和检查
- Participating in internal and external audits and inspections
- 与监管事务部合作，确保符合当地和国际法规
- Collaborating with regulatory affairs to ensure compliance with local and international regulations
- 监控和分析批次放行绩效指标
- Monitoring and analyzing batch release performance metrics
- 实施持续改进计划，提高批次放行效率和有效性
- Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness
- 参加质量警报/产品警报会议，并确保在这些会议期间采取的调查和行动能够决定批次的处置
- Attend quality alert/product alert meetings and ensure that investigations and actions taken during these meetings determine the handling of the batch.
- 在由全球领导的 CoP 中代表工厂，如果要求，参与 CoE 并确保当地沟通
- Represent the factory in the globally leading CoP, participate in the CoE if required, and ensure local communication.
- 运营团队内需要现场进行投诉调查的联系人（协调调查报告）
- The contact person within the operations team who needs to conduct on-site complaint investigations (to coordinate investigation reports).
关键角色（决定/D，A，分享/I）
- 未遵守 GMP 规则时请求更正 （D）
- Request corrections when GMP rules are not respected (D)
- 优先考虑质量和合规目标 （A）
- Prioritize quality and compliance objectives (A)
- 积极实施来自内部和外部审计缺陷的与质量问题相关的补救措施 （D）
- Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
- 请求质量改进计划和策略 （D）
- Request quality improvement initiatives and strategies (D)
- 确定需要采取的差异和纠正/预防措施 （D）
- Identify discrepancies and corrective/preventive actions that need to be taken (D)
- 在车间将 GMP 执行失败的情况上报给高级管理层（I）
- Escalate to upper management any failure in GMP execution on shopfloor (I)
- 将质量绩效、纠正措施、发现和预防措施告知相关利益相关者和团队成员 （I）
- Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)
- 就如何展示主题和回答具体问题提供建议 （A）
- Advise on how to present a topic and answer specific questions (A)
- 就风险管理策略和计划提供建议 （A）
- Advise on risk management strategies and plans (A)
- 就促进以质量为中心的文化的举措提供建议 （A）
- Advise on initiatives to promote a quality-focused culture (A)
- 批准批处置文档并更新相应的数字工具，以允许放行 （D）
- Approve documentation for batch disposition and update corresponding digital tool to allow release (D)
- 实施风险缓解策略，以解决批次放行流程中的潜在质量问题 （D）
- Implement risk mitigation strategies to address potential quality issues in the batch release process (D)
- 解决问题和偏差，并对批次做出处置决定（D）
- Resolve issues and deviations and take disposition decision on lots (D)
- 分析绩效指标并在出现问题时上报 （I）
- Analyze performance metrics and escalate in case of issues (I
- 向高级管理层告知批次放行绩效指标和趋势，以支持数据驱动的决策 （I）
- Informing senior management about batch release performance metrics and trends to support data-driven decision-making (I)
- 批准在质量警报会议期间采取的行动（D）
- Approve actions taken during Quality Alert meeting (D)
- 投诉调查建议 （A）
- Advise on complaint investigation (A)
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
- 至少 2 年制药行业质量保证经验
- Minimum of 2 years experience in quality assurance within the pharmaceutical industry
- 熟悉良好生产规范 （GMP） 和质量保证原则
- Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
预期的技术技能
Expected Technical skills
- 能够分析复杂数据并确定趋势、问题和解决方案
- Ability to analyze complex data and identify trends, issues, and solutions
- 在所有质量保证活动中高度准确并注重细节
- High level of accuracy and attention to detail in all quality assurance activities
- 较强的口头和书面沟通技巧，能够与团队成员和监管机构有效互动
- Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
- 熟练识别问题并实施有效的纠正措施
- Proficiency in identifying problems and implementing effective corrective action
- 能够同时管理多个项目，确保及时完成并遵守质量标准
- Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
语言
Language
- 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
