Site quality head

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

La diversité et l’inclusion sont les piliers de la manière dont Sanofi fonctionne et font partie intégrante des valeurs de la société. Nous respectons la diversité de nos collaborateurs, tout comme celle de leurs parcours et expériences. Afin de bénéficier de la richesse qu’apporte la diversité, Sanofi s’engage à donner l’exemple en matière d’inclusion et à favoriser un environnement de travail où les différences peuvent prospérer et contribuer à aider les patients à retrouver une vie meilleure.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.