Sanofi US | Global Head of Quality Audit Inspection & Intelligence Advocacy

Main responsibilities

• 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 team is comprised of ~40 people in 7 countries in USA, Euro
• In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
• 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.

Requirements

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

Sanofi US

Sanofi US is an employer hiring in India. In its own words: "Sanofi is a research & development-driven, AI-powered healthcare biopharmaceutical company committed to improving lives through innovative medicines & vaccines."

Its finance, accounts, audit and tax openings in India are mostly in Cambridge and United States.