Quality Design & Qualification Specialist - VIE Contract

Quality Design & Qualification Specialist - VIE Contract

Location: Germany, Frankfurt

Target start date: 01/12/2025

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 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.

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi's Work Abroad Program, iMove, offers jobs -assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.