**Job Title:** Site Quality Head **Location:** Geel, Belgium **Job Type:** Permanent - full time **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. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. **About the job:** The Head of Site Quality is a senior leadership position responsible for ensuring comprehensive quality oversight and regulatory compliance across all site operations. As the site's quality authority, you will lead the quality management system, drive a culture of excellence, and ensure the site maintains valid manufacturing licenses and regulatory compliance at all times. This role operates independently from manufacturing while partnering closely with site leadership to deliver quality products that improve patients' lives. KEY RESPONSIBILITIES **Quality Leadership & Strategy** + Develop and implement the site quality roadmap aligned with business needs and global quality objectives + Lead the site quality management system ensuring continuous compliance and certification + Foster a strong quality culture throughout the organization + Ensure inspection readiness and manage regulatory inspections from health authorities (FDA, EMA, others) **Regulatory Compliance & Operations** + Ensure all activities comply with GMP/GDP regulations and Sanofi global standards + Maintain valid manufacturing licenses and marketing authorizations + Oversee Quality Control operations to ensure products meet specifications + Conduct product quality reviews to verify manufacturing process consistency + Ensure products remain compliant with approved dossiers **Continuous Improvement & Team Leadership** + Drive continuous improvement and innovation in quality systems and processes + Lead, develop, and inspire the quality team + Implement risk-based approaches to quality management + Collaborate with global quality teams on system improvements **You will have decision-making authority for:** + Quality oversight of site processes and batch disposition + Establishing site quality and compliance objectives + Compliance actions in response to audits and inspections + Quality strategic decisions for major projects (CAPEX, transfers, new products) **About you :** **Education & Language** : Bachelor's degree in Science/Engineering/Pharmacy (Master's/PhD preferred); fluent in Dutch and English (written and spoken) **Experience** : Minimum 10 years in pharmaceutical quality management; experience with multiple product types and new product launches preferred **Regulatory Expertise** : Deep knowledge of GMP/GDP regulations (ICH, FDA, EMA); proven track record managing regulatory inspections **Technical Skills** : Expert in pharmaceutical regulations, manufacturing processes, inspection readiness, and quality risk management **Leadership** : Demonstrated experience in quality leadership roles; ability to develop high-performing teams and manage stakeholders **Strategic Thinking** : Strong decision-making skills under uncertainty; change management and project management expertise **Core Behaviors** : Results-oriented, collaborative, innovative, with a focus on continuous improvement and commitment to quality excellence and patient safety POSITION SCOPE + Site Headcount: approx. 800 employees + Quality Team Size: approx. 200 employees + The Geel site produces therapeutic proteins from cell culture for biological medicines (i.e. monoclonal Antibodies and Enzymes) + Regulatory Markets: Local to global (FDA, EMA, and others) WHAT WE OFFER + Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale. + Transform lives worldwide by delivering life-changing treatments anywhere, anytime. + Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever. **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-BE \#LI-Onsite **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)