What are the responsibilities and job description for the Head of GMP GDP Audit and Inspection - Commercial position at Sanofi?
Job Title: Head of GMP GDP Audit and Inspection - Commercial
Location: Bridgewater, NJ
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.
Are you ready to shape the future of Quality Audits? As the Head of GMP GDP Audit, Inspection – Commercial at Sanofi, you'll lead a team ensuring our commercial portfolio meets regulatory standards and industry best practices. This pivotal role covers the breadth of Sanofi’s rich commercial portfolio for GMP GDP audits, regulatory inspections and offers strategic guidance on quality matters. The role reports directly to the Head of Sanofi Quality Audit Inspection Intelligence & Advocacy. Join us to drive quality and compliance in innovative ways.
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:
Design, develop and implement risk-based Auditing Strategies for GMP GDP Network
Lead team to prepare, perform and follow-up Mock Inspection activities across Manufacturing & Supply Network to ensure preparedness
Support Inspections by major International Regulators across Manufacturing & Supply Network
Core Member of GMP GDP Quality Governance Committee, deputy decision-maker for Head of Quality Audit, Inspection & Intelligence
Acts as main point of contact in “Reverse Due Diligence” activities, and participates in Due Diligence, as and when needed
About You
Education/Experience:
Minimum master’s degree in science, pharmacy, engineering, data science, or equivalent with at least 15 years relevant experience in the pharmaceutical, biotech, medical device, or related industries or at a major regulatory authority
Soft and technical skills:
Strong understanding of manufacturing processes, validation principles, risk assessment methodologies, contamination control and Annex 1, and statistical techniques
Eight or more years of experience as an auditor and/or inspector
Five or more years previous experience interfacing with Regulatory Authority Inspectors from different regions of the world.
Extensive knowledge of Quality Systems and Data Integrity
Inclusive, transformational, pragmatic leadership
Change management
Excellent communicator
Languages:
Fluent English, French speaking 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.
“Our team aligns around core values of integrity, innovation, expertise, and collaboration. This position is ideal for a dynamic Quality Leader who loves GMP audit and inspection, thrives on daily learning in a fast-paced and diverse setting, surrounded by amazing colleagues.”
Helen Motamen, Head of Sanofi Quality Audit Inspection Intelligence & Advocacy
BRIDGEWATER, NJ ONLY – Office Location Update
Sanofi's Bridgewater, NJ office is scheduled to relocate to Morristown, NJ on or around March 24, 2025 and this role will then be based in Morristown, NJ.
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.
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