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 requirementsDriving site quality performance and business continuityEnsuring the release of products manufactured at site, with the right quality and at the right time in compliance with regulationNominate Quality person for batch dispositionRepresenting Site Quality in front of Health AuthoritiesEnsuring application and maintenance of the site manufacturing licenseDriving site inspection readinessDeveloping and engaging site quality team with the right quality skills, mindset, leadership, and cultureDefine site quality risk management program and involved in related decisions for remediationDecide on product quality event reportability and maintain the Site Master FileEnsure adequate GMP training of site employeesOperational management of site Quality management organization including Quality Control, Quality Assurance, Quality system and Compliance as well as Regulatory departmentStrong interaction with sister sites within the clusterMonitoring of regulatory changes, new authority requirements in the EU, WHO, ANVISA, EAEU, other regulatory regionActive 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 documentsExperience in authority inspection, capability in communication with Authority representativesExperience  in risk management and simplification, harmonizationEducation: Preferably degree in Pharmacy, or degree in Chemistry, Biochemistry, Biotechnology, Chemical engineer or Microbiologist eligible for registration as a Qualified PersonSoft and technical skills:Strong knowledge in GMP and related regulation in min. EU region, but preferably knowledge in EAEU, WHO, ANVISA regulationsOperational understanding of aseptic manufacturing, especially knowledge in EU GMP Annex 1 regulationbasic knowledge in MicrobiologyTechnical skills ability to meticulously review and manage documents to ensure accuracy, completeness, and compliance with regulatory standardsDemonstrated experience in managing one or several quality systems and processes in the past with team management experienceproject management skillscapability of risk takingexperience in efficiency improvement, digitalization projectsgood leadership skills, talent developmentLanguages: Hungarian and English (fluent)

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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 and check out our Diversity Equity and Inclusion actions at sanofi.com!