Head Of Quality Management System H/F Sanofi

Détail du poste

Are you passionate about driving excellence in bio-pharma quality? Do you thrive on leading transformative initiatives in a global environment? Sanofi is seeking a visionary leader to spearhead our Global Quality Management System.

This is a key role in ensuring coherent development and roll-out of the Sanofi Quality Management System in line with regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi quality policy across the Sanofi entities. The role provides a key link between the Global Quality and Operational Quality Units & Global Functions.

About the job

The mission of the Global Quality Management System is to drive the Sanofi Quality Management System built upon the strategic orientations of the Company, the principles defined in International Pharmaceutical Quality System and applicable health-related regulations to assure patient safety and product quality and services life-cycle management, by leading the transformation towards QMS harmonization, simplification and digitalization.

Main responsibilities :
- Development of a Culture of Quality and Performance across Sanofi global & operational entities,
- Development and execution of the GxP processes supporting the Quality Management System,
- Development and simplification of the Global Quality System Document contents and structure to enhance compliance with applicable GxP regulations and guidelines,
- Development and execution of new Content Management System
- Contribute to the digital transformation of the Global Quality Systems
- Development and execution of strategic plan for Global Quality Trainings supporting the transformation of the company, including digitalization.
- Development and execution of a Proactive Quality Risk Management Program,
- Development and execution of a robust internal process for product portfolio quality & registration dossier CMC risks at global and site level Regulatory Site Officers,
- Development of a Global Quality Communication Plan and manage the Global Quality communication thought various channels,
- Ensures monitoring, reporting and risk mitigation plans are in place for Emerging Risks,
- Management of the quality alerts, product alerts of quality origin and product recalls and the development/ execution of related mitigation transversal action plans,
- Optimization of the product registration dossier CMC change control process,
- Supports the development of a High-Performance Team across the department,
- Supports the Individual Development Plans for employees in the department,
- Continuously evolves the organizational activities across the various departments to achieve the next level of best-in-class Quality Management System.
- Ensures the obligations of the delegation Pharmacien Responsible Interimaire French regulations are effectively met (compliance with the provisions described in Article R. 5124-36 of the French Public Health Code) and supports ANSM inspections for GMP/GDP regulated SWI activities.

About you

Education :
- Master's degree in Pharmacy or science discipline or equivalent
- 15+ years of operational experience, t/o about 10 years in leadership function (manufacturing and supply, R&D, Quality assurance) in biotech, pharmaceutical industry or medical devices

Technical skills :
- Extended knowledge & experience in Quality Management Systems processes and associated tools
- Project Management experience involving proven capability to strategize, collaborate and execute on the successful completion of process improvements and digital capabilities
- Experience with working transversally across multiple entities in a multicultural environment
- Knowledge in Development, Commercial Manufacturing, Country Organization, Distribution and Post-marketing activities,

Soft skills :
- Ability to navigate complex issues and develop strategic actions,
- Ability to influence decisively with action oriented, results driven, compliance and patient focused mindset,
- Autonomously working and taking decisions in line with Sanofi Global Quality Policy, Standards and Processes.
- Strategic thinker with a strong compliance mindset; result-driven, can-do attitude, solution oriented, change-agent, patient centric mindset, resourceful and innovative.

Leadership behaviors
- Enterprise Leader - Have the E2E vision of the business, prioritizing the common interest for the benefit of Sanofi and the patients. Connect the dots for their teams and keep them engaged with the vision.
- Transformation Leader - Act as change management and culture role model to foster employee's engagement and build a psychologically safe and collaborative workplace.
- Decision Maker - Take timely and data-based decisions in a fast moving and complex environment to drive performance and progress. Promote an environment where decisions are taken at the right level using DAI.
- Performance Champion - Embrace digital innovation, AI, GenAl to democratize data and drive continuous improvement initiatives to enhance efficiency, quality, safety, and cost effectiveness.
- Business Ally - Understand business landscape, Industry & business/client groups knowledge to translate the challenges & bring added value. Stay current with global external trends and integrate insights into strategies achieving
- People Developer - Unleash the potential of each one and prepare the leaders of the future. Take bold decisions to ensure the right talents are at the right place.

Languages :
- French (Fluent); English (Advanced); additional European language as a plus.

Why choose Sanofi?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether IT's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

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, disability, or gender identity.

Watch our and check out our Diversity Equity and Inclusion actions at !

La diversité et l'inclusion sont les piliers de la manière dont Sanofi fonctionne et font partie intégrante des valeurs de la société. Nous respectons la diversité de nos collaborateurs, tout comme celle de leurs parcours et expériences. Afin de bénéficier de la richesse qu'apporte la diversité, Sanofi s'engage à donner l'exemple en matière d'inclusion et à favoriser un environnement de travail où les différences peuvent prospérer et contribuer à aider les patients à retrouver une vie meilleure.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.