_This job offer is accessible to all, regardless of gender._ _Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec des interlocuteurs anglophones internes et externes au groupe. L’anglais et le français seront utilisés quotidiennement._ **Job Title:** Site Quality Head **Hiring Manager :** Matthieu Puyet **Grade:** L5 **Location:** Val de Reuil, France **Job Type:** Permanent - full time _About the job_ We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Within Manufacturing and Supply Fonction, our Val-de-Reuil site is the reference site for the production of the flu vaccine (130 million doses produced each year) and the yellow fever vaccine, which are then distributed worldwide. Your job, as **Site quality Head** within our global vaccines business, will be to drive site quality operations in Val de Reuil and to **deliver safe, high-quality products aligned with global standards and regulations, while contributing to our success.** **Main reponsibilities :** + **Ensure Regulatory Compliance:** Lead the implementation of a robust Quality System to guarantee full compliance with cGMP, regulatory requirements, and product registration files across all industrial operations. + **Oversee Product Quality & Safety:** Ensure that all products meet the highest standards of quality, safety, and efficacy from manufacturing to market release and throughout their shelf life. + **Manage QC Operations:** Supervise Quality Control testing to ensure timely, cost-effective, and compliant product availability for global markets. + **Support Development & Transfers:** Integrate quality requirements into development and tech transfer processes to streamline industrialization and regulatory approvals. + **Act as Site Quality Representative:** Serve as the primary contact for health authorities on matters of product quality, safety, and compliance. + **Drive Continuous Improvement:** Lead initiatives to enhance quality, safety, and compliance across the site and with external partners, aligned with corporate and global strategies. + **Contribute to Site Leadership:** Play a key role in defining and executing site-wide objectives as a member of the Val de Reuil Leadership Team (VLT) **SCOPE AND DIMENSIONS** The function covers the entire scope of GMP activities within Val de Reuil Manufacturing and Supply activities. The Site Quality Organization equals to more or less 400 headcounts. The key performance indicators for the site are : Quality indicators, regulatory inspections. Whilst remaining aligned with the site goals and strategy, keeping a teamwork approach and based on facts and evidences, you will have the authority : + To release or reject any of the materials, components and manufactured batches according to the relevant GMP and registered specifications and cGMP requirements. + To authorize or stop any of the manufacturing activity based on evidences of GMP and Regulatory compliance. + To define mandatory requirements to be included in GMP projects related to any of the GMP environment facilities, utilities, equipment, process, methods and products. + To review and approve all quality documents prior to their respective effective date and to review and approve all of the quality reports prior to their respective close-out. + To push for decisions and actions with regards to GMP and RA compliance in any of the GMP area for Val de Reuil M&S. _About you_ + **Education & Experience:** Advanced degree (BAC +5 or higher) with at least 15 years of proven leadership in both manufacturing and quality operations. Being a qualified pharmacist with the ability to release batches (Pharmacien Responsable Délégué) is a plus + **Strategic Leadership:** Demonstrated success in driving results, fostering cross-functional collaboration, and leading change initiatives. + **Regulatory Expertise:** In-depth knowledge of global cGMP standards (e.g., WHO, ICH, FDA, EU GMP, TGA, BGTD, Japan) and regulatory expectations. + **Technical Mastery:** Strong technical background in biotech manufacturing processes and quality systems. + **Soft Skills:** High-level communication, adaptability, and influence to align quality goals with site and corporate strategies. _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. + 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. + Play an instrumental part in creating best practice within our manufacturing facility \#LI-FRA \#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)