Quality Assurance FFIP First Shift Lead
Swiftwater, Pennsylvania Permanent Posted on Mar. 14, 2025 Closing on Apr. 04, 2025Job 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 Technology Audit & Inspection at Sanofi, you'll lead a team ensuring our technology meets regulatory standards and industry best practices. This pivotal role supports regulatory inspections and offers strategic guidance on quality matters, reporting directly to the Head of Sanofi Quality Audit Inspection Intelligence & Advocacy. Join us to drive innovation and quality across global operations.
At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need. It’s about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before. Join our Global Quality organization as Head of Technology Audit & Inspection and you can help make it happen!
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:
Develops Sanofi’s audit strategy and risk-based approach for Technology Audits in collaboration with internal stakeholders
Technology Audits include medical devices, drug-device combination products, Computerized System Validation, In Vitro Diagnostic (IVD), Radio Pharma, Software as Medical Devices (SaMDs), and Digital topics
Developing Sanofi’s approach to auditing AI
Contributing to Sanofi’s Inspection strategy for Inspections with Technology in scope
Leading a forward-leaning team of international auditors
About You
Experience & Education
Minimum master’s degree in science, pharmacy, engineering, data science, or equivalent with at least +12 years relevant experience in the pharmaceutical, biotech, medical device, or related industries
Previous experience as an auditor or inspector
Line management experience for teams based in Americas and/or Europe
Soft and technical skills
Strong command of regulatory requirements associated with scope of role
Fluent in Data Integrity requirements across GXPs
Familiar with Data Privacy and Cybersecurity requirements across GXPs
Proficiency in programming language(s) such as Python, JAVA, C++, R
Inclusive, transformational, pragmatic leadership and change management
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.
“The rapid evolution of technology is both thrilling and inspiring! This position is ideal for a dynamic and innovative Quality Professional who thrives on daily learning in a fast-paced 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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Pursue progress. Discover extraordinary.
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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
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 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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