Fabrication et Approvisionnement
Là où les miracles
de la science
deviennent une réalité pour les patients

About the job

As Head of Site Quality, you’ll be responsible for implementing Sanofi's Quality Policy, ensuring regulatory compliance, and driving quality performance across all site operations while serving as the primary quality representative to Health Authorities. The role encompasses strategic quality leadership including batch release decisions, inspection readiness, manufacturing license maintenance, and developing a high-performing quality team to ensure products are delivered with the right quality, on time, and in full regulatory compliance. Ready to get started?

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:

• Preparation of quality strategy plan and implementation of the Sanofi Quality Policy at site, according to regulatory requirements
• Driving site quality performance and business continuity
• Ensuring the release of products manufactured at site, with the right quality and at the right time in compliance with regulation
• Nominate Quality person for batch disposition
• Representing Site Quality in front of Health Authorities
• Ensuring application and maintenance of the site manufacturing license
• Driving site inspection readiness
• Developing and engaging site quality team with the right quality skills, mindset, leadership, and culture
• Define site quality risk management program and involved in related decisions for remediation
• Decide on product quality event reportability and maintain the Site Master File
• Ensure adequate GMP training of site employees
• Operational management of site Quality management organization including Quality Control, Quality Assurance, Quality system and Compliance as well as Regulatory department
• Strong interaction with sister sites within the cluster
• Monitoring of regulatory changes, new authority requirements in the EU, WHO, ANVISA, EAEU, other regulatory region
• Active participation in Global or HUB projects, initiatives

About you:

• Experience: Strong experience in assurance, quality management in the pharmaceutical industry, including in the development, review, and approval of quality system documents
• Experience in authority inspection, capability in communication with Authority representatives
• Experience  in risk management and simplification, harmonization
• Education: Preferably degree in Pharmacy, or degree in Chemistry, Biochemistry, Biotechnology, Chemical engineer or Microbiologist eligible for registration as a Qualified Person
• Soft and technical skills:
• Strong knowledge in GMP and related regulation in min. EU region, but preferably knowledge in EAEU, WHO, ANVISA regulations
• Operational understanding of aseptic manufacturing, especially knowledge in EU GMP Annex 1 regulation
• basic knowledge in Microbiology
• Technical skills ability to meticulously review and manage documents to ensure accuracy, completeness, and compliance with regulatory standards
• Demonstrated experience in managing one or several quality systems and processes in the past with team management experience
• project management skills
• capability of risk taking
• experience in efficiency improvement, digitalization projects
• good leadership skills, talent development
• Languages: Hungarian and English (fluent)

#LI-EUR

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Toujours Progresser. Découvrir l’Extraordinaire.

Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.

Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.