Présentation
About the Job
As Quality Compliance Head for Manufacturing & Supply Specialty Care GBU, you will provide critical oversight of cGMP compliance across our network. You'll support sites in inspection readiness, manage health authority interactions, and assess implementation of Sanofi's Quality Management Systems in accordance with company and regulatory requirements.
You will lead cGMP Regulatory & Compliance projects through transversal activities across our site network. This role serves as a vital link between Site Quality Units, the M&S SpeCare GBU Quality Unit, and Global Operational Quality Units.
Key Responsibilities
- Lead cGMP compliance projects aligned with M&S SpeCare GBU Quality Operations strategy
- Support inspection readiness through quality system assessments and gap identification
- Guide external inspection preparation, management, and health authority responses
- Review effectiveness of sites' Quality Systems during visits and interactions
- Contribute to Global Quality Dashboard reporting for management visibility
- Coordinate IRISC activities for the M&S SpeCare GBU
- Champion quality culture and continuous improvement across all organizational levels
- Support training initiatives on Sanofi Global Quality System and regulatory requirements
- Facilitate knowledge sharing through webinars and best practice exchanges
- Provide quality risk management support and contribute to Risk Management Reports
- Participate in digital transformation initiatives aligned with Global Quality strategy
- Collaborate with quality experts across GBUs and global quality functions
About You
Experience:
- Advanced knowledge of pharmaceutical and medical device regulations
- In-depth experience of Biologics Operations
- Deep experience in interacting with health authorities (FDA, ANSM)
- sound knowledge/experience in Biologics
Education:
- Pharmacy degree or equivalent
- Master's Degree in Pharmaceutical Technology, Life Sciences or Engineering
Languages:
- Fluent in English
- additional French language knowledge welcome – but not a must
Technical Skills:
- Regulatory expertise
- Project management proficiency
- Strong analytical capabilities
- Quality & Risk Management experience
- Continuous improvement methodologies
- Knowledge in digital tools and new technologies
Soft Skills:
- Business partnering and stakeholder management
- Excellent communication and networking abilities
- Influential and change-oriented mindset
- Customer-focused approach
- Transversal collaboration
- Results-driven with decision-making capabilities
- Strategic thinking
Location: Gentilly, France or Frankfurt, Germany
Work Arrangement: up to 40% Remote working option
Travel: 20% expected
Position Type: Permanent, Full-time
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, color, 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!
Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d'inclusion et créer un environnement de travail où ces différences peuvent s'épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous.
Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.