Global Head of Quality Audit and External Liaison

Location: Remote, US

About the role

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. The team is comprised of ~40 people in 7 countries in USA, Europe, and other regions.

Scope includes 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 scope covers medical devices, computerized systems, in-vitro diagnostic (IVD) and digital technologies including artificial intelligence. Diverse product portfolio spans Specialty Care, Vaccines, General Medicines, Consumer Health Care (until completion of Transition Agreement). Lifecycle activities cover 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 include development of new legislation, evolution of existing legislation, interpretation/enforcement of legislation.

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Their deep understanding of the immune system and innovative pipeline enables them to invent medicines and vaccines that treat and protect millions of people around the world.

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.

Qualifications

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
• Bachelor's degree in a related science required

Preferred Qualifications

• Previous experience as an auditor, interfacing with Regulatory Authority Inspectors, and/or Regulation Intelligence/Advocacy
• French speaking

Benefits

• Thoughtful, well-crafted rewards package that recognizes contribution and amplifies impact
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
• At least 14 weeks' gender-neutral parental leave
• Opportunities to grow talent and drive career through promotion or lateral move, at home or internationally
• 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