Job title: Regional stability monitoring manager

Location: BudapestJob 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 directionDevelop 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 activitiesEnsure strict compliance with established internal and external regulations and guidelines related to stability management for ongoing activities, including protocol development and report generationDemonstrate knowledge of ICH stability regulationsMonitor and analyze stability testing data using statistical software, ensuring accuracy, reliability, and adherence to regulatory requirementsCoordinate with site-specific subject matter experts (SMEs) to gather insights and ensure comprehensive understanding of stability testing resultsPrepare and review stability reports to comply organizational standardsCollaborate with cross-functional teams to implement process improvements and address any deviations or issues for stability managementImplement and oversee training programs to ensure team members are proficient in stability management procedures and regulatory requirementsEvaluate 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 recordSoft 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 environmentsTechnical skills: Thorough understanding and practical experience in applying ICH guidelines to ensure compliance in stability studies & quality risk managementOther skills: LIMS, Word, Excel, statistical software, GxP experience, stability regulationEducation: Master's Degree in a scientific background or similar areaLanguages: 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.

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
 

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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.

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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!