Head of GMP GDP Audit and Inspection - Commercial

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 :

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.

GD-SG

LI-GZ

LI-Onsite

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, ability or gender identity.

Watch our ALL IN video () and check out our Diversity Equity and Inclusion actions at sanofi.com () !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi ()

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube ()