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Quality Design & Qualification Specialist - VIE Contract

Quality Design & Qualification Specialist - VIE Contract

Quality Design & Qualification Specialist - VIE Contract

Quality Design & Qualification Specialist - VIE Contract

Sanofi

Pharmazeutische Produkte, Arzneimittel

Frankfurt am Main

  • Art der Anstellung: Vollzeit
  • 63.500 € – 89.000 € (von XING geschätzt)
  • Vor Ort
  • Aktiv auf der Suche

Quality Design & Qualification Specialist - VIE Contract

Über diesen Job

Frankfurt am Main, Germany

At a glance

Our teams produce and deliver over 4 billion units of medicines and vaccines every year, ensuring every breakthrough gets to the people who need it most.
Our state-of-the-art facilities, AI-powered smart factories, and cutting-edge automation are redefining what’s possible: ensuring treatments reach patients faster, safer, and more sustainably than ever before. This is where your skills, ambition, and passion can shape the future of healthcare.

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.

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.

#LI-EUR

Extraordinary .

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com

Gehalts-Prognose

Unternehmens-Details

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Sanofi

Pharmazeutische Produkte, Arzneimittel

10.001 oder mehr Mitarbeitende

Frankfurt am Main, Deutschland

Bewertung von Mitarbeitenden

Vorteile für Mitarbeitende

Flexible Arbeitszeiten
Home-Office
Kantine
Restaurant-Tickets
Kinderbetreuung
Betriebliche Altersvorsorge
Barrierefreiheit
Gesundheitsmaßnahmen
Betriebsarzt
Training
Parkplatz
Günstige Anbindung
Vorteile für Mitarbeitende
Firmenwagen
Smartphone
Gewinnbeteiligung
Veranstaltungen
Privat das Internet nutzen
Hunde willkommen

Unternehmenskultur

Unternehmenskultur

1020 Mitarbeitende haben abgestimmt: Sie bewerten die Unternehmenskultur bei Sanofi als ausgeglichen zwischen traditionell und modern.Dies stimmt ungefähr mit dem Branchen-Durchschnitt überein.

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