**About** **_the Job_** As Quality Compliance Head for Manufacturing & Supply Specialty Care GBU, you will provide critical oversight of cGMP compliance across our network. You'll support sites in inspection readiness, manage health authority interactions, and assess implementation of Sanofi's Quality Management Systems in accordance with company and regulatory requirements. You will lead cGMP Regulatory & Compliance projects through transversal activities across our site network. This role serves as a vital link between Site Quality Units, the M&S SpeCare GBU Quality Unit, and Global Operational Quality Units. **Key Responsibilities** + Lead cGMP compliance projects aligned with M&S SpeCare GBU Quality Operations strategy + Support inspection readiness through quality system assessments and gap identification + Guide external inspection preparation, management, and health authority responses + Review effectiveness of sites' Quality Systems during visits and interactions + Contribute to Global Quality Dashboard reporting for management visibility + Coordinate IRISC activities for the M&S SpeCare GBU + Champion quality culture and continuous improvement across all organizational levels + Support training initiatives on Sanofi Global Quality System and regulatory requirements + Facilitate knowledge sharing through webinars and best practice exchanges + Provide quality risk management support and contribute to Risk Management Reports + Participate in digital transformation initiatives aligned with Global Quality strategy + Collaborate with quality experts across GBUs and global quality functions **About** **_You_** **Experience:** + Advanced knowledge of pharmaceutical and medical device regulations + In-depth experience of Biologics Operations + Deep experience in interacting with health authorities (FDA, ANSM) + sound knowledge/experience in Biologics **Education:** + Pharmacy degree or equivalent + Master's Degree in Pharmaceutical Technology, Life Sciences or Engineering **Languages:** + Fluent in English + additional French language knowledge welcome – but not a must **Technical Skills:** + Regulatory expertise + Project management proficiency + Strong analytical capabilities + Quality & Risk Management experience + Continuous improvement methodologies + Knowledge in digital tools and new technologies **Soft Skills:** + Business partnering and stakeholder management + Excellent communication and networking abilities + Influential and change-oriented mindset + Customer-focused approach + Transversal collaboration + Results-driven with decision-making capabilities + Strategic thinking **Location** : Gentilly, France or Frankfurt, Germany **Work Arrangement** : up to 40% Remote working option **Travel** : 20% expected **Position Type** : Permanent, Full-time **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, 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) ! 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)