**Job title** **职位名称** : China EM&S Quality Head + Location工作地点： Shanghai 上海 **About the job工作职责** 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? **Main responsibilities** **职责描述：** _Please indicate here the main job responsibilities_ _请列举该职位的主要工作职责_ _。_ 1. Quality and Compliance: **Quality Management System:** • Define, implement & maintain Quality Management Systems for EM&S China products • Ensure compliance with NMPA GMP requirements, China volume-based procurement policies, and Sanofi GOPs • Manage local regulatory requirements specific to China's biologics manufacturing regulations • Oversee implementation of quality systems specific to large molecule manufacturing **CMO Oversight:** • Perform risk ranking for CMOs as per Sanofi Directive with special consideration for biologics capabilities • Monitor CMO compliance with China's NMPA requirements and biologics manufacturing standards • Identify and mitigate risks related to CMO compliance including small molecules, large molecules and biological product manufacturing • Track CMO performance through KPIs **Quality Agreement:** • Establish Quality Agreements between Sanofi and CMOs incorporating China-specific requirements • Ensure agreements address biological product manufacturing requirements **Technology Transfer:** • Manage technology transfers including small molecules, large molecules and biological products • Ensure compliance with NMPA technology transfer guidelines • Oversee analytical method transfers 2. Regulatory and Compliance **Product Dossier Management:** • Manage product dossiers according to NMPA requirements • Ensure compliance with China's regulations • Oversee product registration requirements **Regulatory Compliance:** • Maintain regulatory status at External Manufacturing sites per NMPA guidelines • Handle regulatory queries for both chemical and biological products • Stay current with evolving NMPA regulations and volume-based procurement policies 3. Projects and Business Development • Support CMO selection including small molecules, large molecules and biological product manufacturing capabilities • Participate in due diligence activities for new partnerships in China • Evaluate technical capabilities of potential CMOs 4. Team Management • Build and lead a qualified quality team with biologics expertise • Ensure team development in both small and large molecule quality oversight • Provide technical guidance on biological product quality matters **About you 任职资格:** _List here ideally the must-haves criteria to be successful on the role._ _请列出胜任该职位所必须具备的条件。_ **Knowledge, Skills & Competencies:** • Expert knowledge of NMPA regulations and guidelines, particularly for biological products • In-depth understanding of biologics manufacturing and quality control processes • Experience with biological product technology transfers • Native-level Mandarin Chinese proficiency (written and spoken) • Excellent English communication skills • Strong leadership and stakeholder management capabilities **Qualifications** **:** • B.Pharm/ M.Pharm / Ph.D/ MS/ MSc in relevant field • 15-20 years total experience in the Pharmaceutical Industry • Minimum 10 years in Quality Function with demonstrated experience in biologics • At least 5 years' experience managing quality systems for large molecules and /or biological products in China • Experience with NMPA inspections and regulatory interactions • Proven track record of successful CMO management in China **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)