Regional Stability Management Manager

• Location: Budapest, Hungary
• Flexible working: hybrid

About the job:

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.

Main responsibilities:

• Lead and oversee the regional Stability Management team, focusing on effective management and strategic direction
• Develop team skills and foster continuous improvement initiatives to enhance operational efficiency and quality in QC stability
• Interface with regional hub leadership to ensure alignment and effective communication on QC stability activities
• Ensure strict compliance with established internal and external regulations and guidelines related to stability management for ongoing activities, including protocol development and report generation
• Demonstrate knowledge of ICH stability regulations
• Monitor and analyze stability testing data using statistical software, ensuring accuracy, reliability, and adherence to regulatory requirements
• Coordinate with site-specific subject matter experts (SMEs) to gather insights and ensure comprehensive understanding of stability testing results
• Prepare and review stability reports to comply organizational standards
• Collaborate with cross-functional teams to implement process improvements and address any deviations or issues for stability management
• Implement and oversee training programs to ensure team members are proficient in stability management procedures and regulatory requirements
• Evaluate and optimize resource allocation to effectively manage stability activities and initiatives
• Serve as a key point of contact for sites during inspections and audits, ensuring compliance and facilitating smooth interactions

About you:

• Experience: >5 years professional experience in pharmaceutical quality control, stability analysis, quality documentation management and proven leadership track record
• Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments.
• Technical skills: Thorough understanding and practical experience in applying ICH guidelines to ensure compliance in stability studies & quality risk management, experience with quality controll system e.g. CAPA, Change Control
• Other skills: GxP experience, stability regulation, Veeva Vault, LIMS, Word, Excel, statistical software
• Education: Master Degree in a scientific (biology, chemistry, biochemical, microbilogy) background or similar area
• Languages: Excellent English communication and writing, proficiency in one of the listed languages preferred: French, German, Italian, Hungarian

Be part of something exceptional. Our Budapest Hub has been recognized for workplace excellence, innovation, and our commitment to putting people first. See the full list of our awards at the end of this posting.

• Office of the Year 2025 – Evolution Award
• Our most recent award – Sanofi is recognized for creating an innovative workspace that supports collaboration and adaptability.
• Marketing Diamond Award 2026 – Employer Branding
• One of the highest honours at Hungary's prestigious Marketing Diamond Awards, recognizing excellence in employer branding.
• BSC Investor of the Year 2025
• Awarded by HIPA, ABSL Hungary, and AmCham Hungary for our contribution to Hungary's business services sector.
• PwC Workforce Preference Survey 2025 – Top 3 Most Attractive Employers
• Ranked 3rd among the most attractive employers in Hungary.
• Hungarian Employer Branding Awards 2025 – Gold & Silver
• Best Strategic Employer Branding Campaign (Gold) and Best Employer Branding Campaign in the Pharma Sector (Silver).

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.