Job Description
About The Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Quality Leadership within our M&S, Global Quality Team , will be to lead l Quality and compliance strategy and drive quality transformation and activities for the Spe Care site's network covering biologics drug substance as well as Fill& Finish, located all over the regions. Main challenge with several major launches to come for Specialty care, as well as the constant growth of Dupixent.
Leads the M&S Specialty Care Quality Operations which comprise the following sites: Framingham, Waterford, Le Trait, Geel, Vitry, Lyon, SFB&O.
Leads the quality modernization and transformation, ensures ownership, understanding and implementation across the M&S Spe Care network.
Ensure delivery of product supply in compliance with Sanofi quality requirements and in time to support patient.
Ensure the best state of compliance and inspection readiness of the Spe Care sites, in a context of launches and high exposure to health authorities.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities - Coordinating the implementation and adherence to Quality Policy across the M&S sites
- Participate in the relationship building with Health Authorities and pharma associations to advocate the Sanofi view. Ensures adequate relationship with regulatory authorities.
- Ensure critical projects deliver on time and in compliance
- Drives Quality performance through optimization of global processes and support to the M&S sites
- Drives mindset change associated to this transformation, including TRT principles application for Quality, strive for being the best network of sites, and simplification/standardization mindset.
- Leads implementation of the Sanofi Quality Policies and the Quality system in M&S Spe Care network.
- Ensures inspection readiness and implementation of annual quality programs at site level.
- Participates in M&S Spe Care Management reviews, ensures appropriate quality input and support for business projects.
- Defines and develops the quality organization by ensuring optimal use of resources and upskilling with a focus on quality and compliance expertise, new technologies, digital shift, and leadership in transformation.
- Assesses performance of Quality Management with operational management. Develops direct reports, find opportunities for career advancement; ensure regular training and education of Pharmacists / Qualified Persons according to respective standards and regulations of the pharmaceutical industry.
- Develops and mentors quality leaders
- Visit and GEMBA WorldWide sites
- Promote DE&I, Employee Safety, Planet Care
Experience About You: - 15 years of experience with U.S. and International CGMP regulations. 10 years minimum experience leading direct reports.
- 10 years of experience with Quality Management Systems. 10 years of experience in troubleshooting, investigation, and root cause analysis. Management experience in at least one other core functional area (Manufacturing, Development, Engineering, Corporate Quality) would be an asset. Experience with consent decrees and other regulatory remediation. Experience with different cultures is important and especially if sites are in different countries.
Soft skills : risk-based decision making, relationship management, change management, transformation mind-set, empowering teams and leading by influence
Leadership Behavior - Enterprise Leader: is able to have the E2E vision of the business, prioritizing the common interest for the benefit of Sanofi and the patients. Can connect the dots for their team and keep them engaged with the vision.
- Transformation Leader: Acts as change management and culture role model to foster employee’s engagement and build a psychologically safe and collaborative workplace.
- Decision Maker: Takes timely and data-based decisions in a fast moving and complex environment to drive performance and progress. Promotes an environment where decisions are taken at the right level.
- Performance Champion: Embraces digital innovation, AI, GenAI to democratize data and drives continuous improvement initiatives to enhance efficiency, quality, safety, and cost effectiveness.
- Business Ally: Understands the business landscape Industry & business/client groups knowledge to translate the challenges & bring added value. Stays current with global external trends and integrates insights into strategies achieving sustainable competitive advantage.
- People Developer: Unleashes the potential of each one and prepares the leaders of the future. Takes bold decisions to ensure the right talents are at the right place.
- Technical skills: Regulations, Biologics
- Languages: Fluent in English, French is a plus
Why Choose Us? - 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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG; ; ; #vhd
Job Tags
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