Job Information职位信息

Job title职位名称: Analytical Expertise & Transfer Manager 分析专业技术与转移经理

• Location工作地点： Beijing北京

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 Analytical Expertise & Transfer Manager within our M&S China-BEI 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?

主要职责

Main Accountabilities

·       主导分析方法转移至实验室，遵循MSAT的所有权管理

·       确保分析方法按照法规指导原则进行验证

·       协调分析验证/转移方案的执行，确保按照承诺的计划时间表进行

·       定期对方法性能进行趋势分析，以确定是否需要重新验证、优化或更换方法

·       为分析方法提供技术专业知识和故障排除支持

·       编写和维护准确的分析方法程序以及分析验证主计划、方案和报告

·       对质量控制人员进行新分析方法和实验室仪器及自动化设备的培训

·       确保所有活动符合法规要求（如FDA、EMA）

·       对分析方法和实验室仪器/自动化设备进行风险评估

·       评估和推荐新的前沿技术和方法以提升质量控制活动，与MSAT和研发部门保持密切合作关系

·       在内部和外部审计及检查期间为QC团队提供支持

·       管理和培训分析专业知识及转移团队

·       执行法规监察以了解行业趋势和法规变化的最新信息，确保持续合规（包括药典）

·       Leading analytical method transfers to the lab following ownership of MSAT

·       Ensuring analytical methods are validated according to regulatory guidelines

·       Coordinating the execution of analytical validation/transfers protocols to ensure it is performed according to the committed scheduled plan

·       Performing periodically trend analysis on method performance to determine the need to revalidate, optimize, or replace the method

·       Providing technical expertise and troubleshooting support for analytical methods

·       Writing and maintaining accurate analytical methods procedures and analytical validation master plan, protocols, and reports

·       Training quality control staff on new analytical methods and lab instruments and automation.

·       Ensuring all activities comply with regulatory requirements (e.g., FDA, EMA)

·       Conducting risk assessments related to analytical methods and lab instruments/automation

·       Evaluating and recommending new state-of-the-art technologies and methods to enhance quality control activities, with a strong relationship with MSAT and R&D

·       Supporting QC teams during internal and external audits and inspections

·       Managing and training analytical expertise and transfer team

·       Performing regulatory surveillance to stay updated on industry trends and regulatory changes to ensure ongoing compliance (incl. Pharmacopoeia)

关键角色Key roles（决定/D，建议/A，分享/I）

·        制定验证方案及可接受标准（A）

·       根据QC实验室产能确定执行计划的时间安排（D）

·       识别优先事项并制定ALCM策略的整改计划（D）

·       分析技术问题并制定故障排除策略（A）

·       决定风险缓解策略（D）

·       根据分析方法相关的发现及CAPA制定整改措施（D）

·       就法规变化及其影响提供建议（A）

·       Definition of validation protocols and acceptance criteria (A)

·       Define execution plans timing according to QC labs capacity (D)

·       Identify priorities and define remediation plan on ALCM strategy (D)

·       Analysis on technical issues and troubleshooting strategies (A)

·       Decide on risk mitigation strategies (D)

·       Define remediation actions from findings and CAPAs related to analytical methods (D)

·       Advise on regulatory changes and their impact (A)

其他职责 Additional Accountabilities

·       HSE职责HSE responsibilities

积极配合HSE管理工作，防止各类事故的发生,积极提出HSE 相关反馈或意见。Proactively response to HSE management works to prevent each type of accident, and proactively propose HSE related feedbacks or advices.

参加每天+QDCI会议，监督本部门+QDCI是否有效开展。Participate in the daily +QDCI meeting to supervise whether the department +QDCI is carried out effectively.

·       赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”，要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.

积极提出节能方案Actively propose energy-saving projects

协调并支持节能项目的制定，积极反馈意见Coordinate and support the development of energy-saving projects and give positive feedback

协调并参与节能项目的执行Coordinate and participate in the implementation of energy-saving projects

参与能源管理体系的内部评审Participate in internal audit of energy management system

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.

Pursue Progress. 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!

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!