EM&S Vaccines - Quality Assurance Leader job opportunity at Sanofi.

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Sanofi EM&S Vaccines - Quality Assurance Leader
Experience: 15-years
Pattern: full-time
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loacation Tokyo, Japan
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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   (p resence 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 and check out our Diversity Equity and Inclusion actions at sanofi.com !

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