Qualification & Validation 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 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:

• Include references to relevant documents essential for the qualification process
• Finalize qualification protocols and reports by adjusting layout and format to meet organizational standards and regulatory requirements
• Communicate the approval of qualification protocols and updates to all relevant stakeholders via Content Management Systems (CMS), ensure timely dissemination of information and updates
• Schedule formal consolidated review and approval meetings for qualification protocols
• Launch and manage the review workflow in CMS, tracking progress and ensuring deadlines are met
• Collaborate closely with the Global Qualification Team Lead, Expert, and Specialist to support qualification activities
• Ensure all documentation complies with overall documentation standards
• Identify opportunities for process improvement in document management and workflow efficiency and implement enhancements to streamline qualification protocol finalization and communication processes

About you

• Experience: Professional experience in general documentation and project 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: CMS, Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point
• Education: Bachelor’s degree in business administration, life sciences, 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!