Quality Design & Qualification Specialist - VIE Contract

• Location: Germany, Frankfurt
• Target start date: 01/12/2025

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

As Quality Design & Qualification Specialist VIE within our Quality team, you will play a critical role in co-developing design and integrated C&Q strategies that meet Food and Drug Administration (FDA), European Medicines Agency (EMA), and Chinese Pharmacopoeia regulations while implementing state-of-the-art Current Good Manufacturing Practices (cGMP) design, qualification and Computer Systems Validation (CSV) processes. Ready to get started?

Join our Quality team in Frankfurt to ensure compliance and excellence in our Insulin Facility Frankfurt (IFF). This is a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Ensure project compliance with Sanofi Standards and Good Practices (GMP) Annex 1, 11 and Annex 15.
• Review of design & Commissioning and Qualification (C&Q) strategy development and execution, including system design and impact assessments, system boundary assessments, function-components criticality assessments.
• Contribute to Quality risk assessments during Design Review and support Process Engineering, MSAT and Operations, work closely with Contamination Control Quality.
• Oversee preparation and execution of Design Qualification (DQ), Factory Acceptance Test (FAT) Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ) and nP-PQ protocols.
• Provide Quality review of Vendor documentation (design documents, specifications, FAT, SAT) of mechanical systems, critical utilities and computerized systems.

About you

Experience:

• Interest or first experience in global project work and multicultural collaboration.

Soft and Technical skills:

• Understanding of Commissioning & Qualification, Process Validation Lifecycle, and Quality by Design.
• Knowledge of biologic product license application process and regulatory requirements.
• Problem-solving mindset.
• Willingness to adapt to new cultural environments.
• Open to relocation and excited to experience life and work in Germany.

Education:

• Master’s degree in Engineering/Science/Pharmacy with Quality focus.

Languages:

• Fluent English (written and verbal).
• German will be a plus.

Why choose us?

• Be part of a pioneering biopharma company where patient insights shape drug development.
• Work at the forefront of AI-powered science that accelerates discovery and improves outcomes.
• Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
• Every year, we distribute over 4 billion units of medicines and vaccines, ensuring people worldwide receive the treatments they trust.

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!

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi