Global Head of Quality Audit Inspection & Intelligence Advocacy

Sanofi; Oregon; Hybrid; USD 248,000 - 358,000; Full time

Job summary

Sanofi in the United States is seeking a Global Head of Quality Audit Inspection & Intelligence Advocacy to drive risk-based audit programs, regulatory inspections, and analytic insights across GXP. This executive will lead with integrity, collaboration, and innovation to secure product launches and ongoing compliance.

You will shape the department roadmap, engage external regulators and industry groups, and leverage data and AI to improve efficiency and knowledge sharing across Manufacturing,

Qualifications

• 15+ years of relevant pharmaceutical/biotech/medical device experience or regulatory authority.
• Strong experience with regulatory and pharmaceutical policy.
• Bachelor's degree in a related science.
• Fluent English.

Responsibilities

• Design, develop and implement the department roadmap.
• Risk-based auditing strategies, tactics, and operations across GXP.
• Regulatory Inspection Activities for routine and Pre-Approval Inspections by International Regulators.
• Support due diligence and reverse due diligence activities.
• Utilize data, technology to drive efficiencies, enhance insights, facilitate knowledge sharing, and simplify.
• Represent Sanofi externally at key industrial and trade association meetings and in working groups.
• Foster a culture of quality and cGMP compliance, engaging all organizational levels to drive continuous improvement.
• Latitude of action: Highly independent with thoughtful risk taking and compliance mindset.
• Role impact: continued right to operate for marketed products.
• Scope: Manufacturing & Supply, Research & Development, Digital, Pharmacovigilance, Commercial, Countries, as well as interfacing with other Auditing and Compliance organizations in Sanofi.

Skills

Fluent English

Transformational leadership

Change management

Education

Bachelor's degree in related science

Job description

Job title: Global Head of Quality Audit Inspection & Intelligence Advocacy

Location: Cambridge, MA or Morristown, NJ

About the Job

The team vision is to become catalysts for providing risk based, predictive & objective assurance, insight, support, intelligence & The team vision is to become catalysts for positive change by identifying the unseen, providing risk based, predictive & objective assurance, insight, support, intelligence & advocacy. The mission is to foster best in class performance by leveraging data, technology, and diverse talents to secure product launches and support compliance through quality audits, regulatory inspections, regulatory surveillance and advocacy. Core values are integrity, collaboration, innovation and expertise.

• All Good X Practice (GXP) domains; Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and Data Integrity.


• Technology, including medical devices, computerized systems, in vitro diagnostic (IVD) and digital technologies including artificial intelligence.


• Diverse product portfolio; Specialty Care, Vaccines, General Medicines, Consumer Health Care (until completion of Transition Agreement).


• Lifecycle activities for products including pre-authorization to submission, submission to launch, commercial (including post-approval commitments and post-approval changes), additional indications (line extensions), divestments, Pharmacopoeia Affairs (USA, Europe, China).


• Legislative lifecycle activities including development of new legislation, evolution of existing legislation, interpretation/enforcement of legislation

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• Design, develop and implement the department roadmap.


• Risk-based auditing strategies, tactics, and operations across GXP. External engagement for intelligence and benchmarking, and advocacy for Sanofi critical topics.


• Regulatory Inspection Activities for routine and Pre-Approval Inspections by International Regulators.


• Support due diligence and reverse due diligence activities.


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


• Represent Sanofi externally at key industrial and trade association meetings and in working groups.


• Foster a culture of quality and cGMP compliance, engaging all organizational levels to drive continuous improvement.


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


• Role impact: continued right to operate for marketed products.


• Scope: Manufacturing & Supply, Research & Development, Digital, Pharmacovigilance, Commercial, Countries, as well as interfacing with other Auditing and Compliance organizations in Sanofi.

Basic Qualifications

• 15+ years relevant experience in the pharmaceutical, biotech, medical device, or related industries or a major regulatory authority. Strong experience with regulatory and pharmaceutical policy.


• Inclusive, transformational, pragmatic leadership and change management. Fluent English.


• Bachelors degree in a related science required.

Preferred Qualifications

• Previous experience as an auditor, interfacing with Regulatory Authority Inspectors, and/or Regulation Intelligence/Advocacy is a plus. 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


• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.


• Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale.


• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Equal Opportunity

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-Remote#vhd

Sanofi Inc. and its U.S. affiliates are equal opportunity employers committed to a culturally inclusive 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.

North America Applicants Only

North America Applicants Only

Salary

The salary range for this position is: $247,500.00 - $357,500.00

Benefits

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Additional Information

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.Sanofi US endeavours to make our career center accessible to any and all users.

Pursue progress , discover extraordinary