Stability monitoring expert

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:

• Check conformity against acceptance criteria in the protocol, ensuring statistical results fall within the permissible range

• Conduct initial data interpretation based on statistical analysis outcomes

• Include data and graphs created by the statistical tool used

• Connect with site-specific SMEs to review, discuss, and interpret analysis results, determine if objective of study has been met

• Identify and report deviations, concluding on their impact to the study

• Summarize findings and write report in accordance with regulatory commitments using CMS guidelines

About you:

·Experience: >5 years professional experience in pharmaceutical quality stability management

·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 Degree in a scientific background or similar area

·Languages: Excellent English communication and writing, proficiency in one of the listed languages preferred: French, German, Italian, Spanish, Russian, Hungarian