Regional stability monitoring manager

Job title: Regional stability monitoring manager

• Location: Budapest
• Job type: Permanent, full time

About the job

Our Team:

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 monitoring 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 report issuance 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
• Other skills: LIMS, Word, Excel, statistical software, GxP experience, stability regulation
• Education: Master's Degree in a scientific background or similar area
• Languages: Excellent English communication and writing

Why choose us?

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
• An attractive, market-oriented salary and cafeteria benefits.
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
• Work from an "Office of the Year 2020" finalist office.

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