Head of GMP GDP Audit, Inspection - Pipeline and Launch

Job Title: Head of GMP GDP Audit, Inspection - Pipeline and Launch

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 Head of GMP GDP Audit, Inspection - Pipeline and Launch within our Quality Audit, Inspection, Intelligence and Advocacy group, will be to foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy.

This heavily patient-centric leadership team role is essential for ensuring that new Sanofi medicines, combination products & vaccines (products) progress through different regulatory gates including submissions to major regulatory authorities, approvals, and launches, while at the same time ensuring compliance and quality across global operations. It ensures that the products in the company's pipeline meet regulatory standards, industry best practices, and internal policies. Key responsibilities include mock inspections, auditing, managing risks, supporting pre-approval inspections, enabling thoughtful risk taking, and offering strategic guidance on regulatory and quality matters. 

This critical leadership role focuses on:

• Supporting Sanofi’s ambition to become the Immunology powerhouse through delivery of R&D pipeline for Sanofi’s strategic assets.

• Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), and PAI to launch.  (Support Launch Engine Projects in Sanofi).

• GXP areas of Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP).

• Additionally, some assets have technology aspects, including medical devices, computerized systems, in-vitro diagnostic (IVD) and digital technologies including artificial intelligence.

• Diverse product portfolio across all GBUs; Specialty Care, Vaccines, General Medicines.

• Scope includes internal and external manufacturing.

• International scope including major regulators; US FDA (USA), EMA (Europe), PMDA (Japan), NMPA (China).

• Core member of the Quality Audit, Inspection, Intelligence & Advocacy Leadership Team.

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 Sanofi’s R&D pipeline across GMP GDP Network.

• Lead team to prepare, perform and follow-up Mock Pre-Approval Inspection activities across R&D Manufacturing & Supply Network.

• Engage with external consulting agencies who are experts in CMC and PAI topics to stay up to date on emerging trends in GMP PAIs.

• Member of Pre-Approval Inspection Management Group (PMG) Governance Committee, deputy decision-maker for Head of Quality Audit, Inspection, Intelligence & Advocacy.

• Support PAIs by International Regulators across R&D Manufacturing & Supply Network.  Support includes preparation, on-site inspection support, and follow-up activities such as CAPA work.

• Support R&D Quality Operations team through Questions & Answers period with Regulators following submission of Sanofi Dossiers.

• Central point of contact within Quality Audit Department for Sanofi Due Diligence activities.

• Utilize data, technology to drive efficiencies, enhance insights, facilitate knowledge sharing, and simplification.

• Management: Lead international team of ~05-07 quality auditors in Americas, Europe.

• Latitude of action: Highly independent with thoughtful risk taking and compliance mindset.

• Role impact:  GXP support of strategic R&D portfolio transformation.

• Scope: M&S, R&D, M&A, CMC Dev, GRA, Global Quality organizations in Sanofi.

About You

Experience, Education, Soft Skills, Technical Skills, Languages

Basic Qualifications

• 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. 

• Five or more years of experience as an auditor or inspector. 

• Five or more years of previous experience interfacing with Regulatory Authority Inspectors for Pre-Approval Inspections, in particular US FDA. 

• Inclusive, transformational, pragmatic leadership, change management.

• Excellent communicator.

Preferred Qualifications

• Previous Experience as a Product Quality Lead in R&D (or equivalent) is preferred. 

• Previous Experience working at US FDA as a Reviewer and/or Investigator conducting GMP Pre-Approval Inspections and/or Routine Surveillance Inspections is preferred. 

• Commercial GMP GDP Quality Audit and Inspection experience. 

• 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.

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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