Head of Site Quality

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.

• 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

• 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)

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