Quality Compliance Head Europe - Specialty Care All Genders H/F Sanofi

Détail du poste

About the Job

AsQuality Compliance Headfor 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

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Chez Sanofi, la diversité et l'inclusion sont au coeur 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.