**_Job title: Q_** **_uality Assura_** **_n_** **_ce Leader (Vaccine)_** **Location** : Japan (Nagoya area) **Work type** : Hybrid remote/on-site --- **_About the job_** **_:_** **_As QA Manager_** – Person in Plant – Vaccines within our External Manufacturing & Supply Vaccines Quality team, you'll serve as the primary quality contact for our Contract Manufacturing Organizations (CMOs) in Japan, ensuring cGMP compliance and quality oversight. Ready to get started? Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization. _EM&S Vaccines Quality_ is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi products. Our quality staff ensures compliance with internal and regulatory requirements, working to disposition intermediate and finished products with minimal risk to quality or product supply. **_About Sanofi:_** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **_Main responsibilities:_** • Act as the primary CMO Quality site contact, providing direct quality and compliance support to 2 Contract Manufacturing Organizations(CMO) in Japan • Serve as quality representative in internal core team meetings and joint meetings with CMOs, coordinating all quality interactions and oversight activities • Review and approve cGMP documents and records including batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, and lab investigations • Ensure all applicable documents receive appropriate Sanofi Subject Matter Expert review in accordance with company procedures and standards • Manage product release processes in accordance with approved specifications and procedures, ensuring compliance with quality requirements • Monitor contractor performance against established Key Performance Indicators (KPIs), report adverse trends, and ensure adequate remediation plans are implemented • Support Sanofi audits and demonstrate understanding of health authority regulations for medicinal product manufacturing (small molecules and biologics) • Lead department management activities including establishing metrics, ensuring project completion, representing the department in meetings, and facilitating cross-functional collaboration **_About you_** **_:_** • **Experience** : 15+ years in GxP or regulated environment with 5+ years in Quality roles; 5+ years supervisory/management experience • **Technical** **expertise** : Strong knowledge of drug product/drug substance manufacturing processes; familiarity with global cGMP and ISO regulations for medicinal products • **Quality skills** : Deep understanding of Quality Assurance principles, concepts, and standards; experience evaluating and applying compliance guidelines to complex situations • **Leadership abilities** : Proven ability to make independent decisions, exercise judgment, and lead in highly matrixed organizations; demonstrated "take the lead" mindset with ability to challenge status quo • **Communication** : Excellent communication and negotiation skills; experience with data analysis, trending, and presenting to multi-functional teams • **Education** : Bachelor's degree in relevant scientific discipline • **Languages** : Fluent in Japanese and business level English required **_Why choose us?_** • Work at the forefront of **AI-driven** research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology • Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare • Make the impossible possible for millions by contributing to breakthrough moments like the world's first RSV toddler vaccine • Lead critical quality oversight for life-saving vaccine manufacturing, ensuring the highest standards of safety and efficacy • Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents • Gain hands-on experience in state-of-the-art manufacturing facilities as Person in Plant at leading CMO sites • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution, including flexible working options, comprehensive healthcare, and well-being programs **_Special Working Conditions:_** • Hybrid remote/on-site position located in Nagoya area (presence at CMO sites at least 3 days per week during production campaigns will be required) --- **Pursue** _Progress_ . **Discover** _Extraordinary_ . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue _Progress_ and 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, gender identity, protected veteran status or other characteristics protected by law. ＃LI-HYBRID **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)