Qualification & Validation Senior Specialist, Report Issuance

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 MS Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global MS teams by acting as a crucial link between our RD 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:

• Ensure data integrity and apply quality rules throughout the qualification process
• Confirm that all data included in qualification reports is accurate and meets established quality standards
• Ensure adherence to overall defined quality standards
• Identify and manage stakeholders involved in the (re-)qualification process and assign roles and responsibilities based on their expertise and involvement in qualification activities
• Provide support to stakeholders involved in the (re-)qualification process on data integrity, quality rules, and their respective roles
  
  

About You

• Experience: Professional experience in data management for qualification
• 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: Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point
• Education: Bachelor’s degree in engineering, pharmacy, chemistry, or a related field
• Languages: Excellent English communication and writing, French or other Languages in addition preferred
  
  

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, disability, or gender identity.

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

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!