Global Head of Quality Audit and External Liaison

Sanofi • Morristown, MA

17d • Remote

About The Position

The Global Head of Quality Audit and External Liaison leads the quality audit and external liaison function across Sanofi’s global operations. The team aims to provide risk-based, predictive and objective assurance, insight, support, intelligence and advocacy, using data, technology and diverse talent to support product launches and compliance. Its work spans GxP domains, technologies, product portfolios, product lifecycle activities and legislative lifecycle activities.

The role designs and implements the department roadmap; leads risk-based auditing strategies and operations; supports regulatory inspection activities; and engages externally for intelligence, benchmarking and advocacy. It has broad reach across Manufacturing & Supply, Research & Development, Digital, Pharmacovigilance, Commercial and countries, while interfacing with other Sanofi auditing and compliance organizations. The position operates with a high degree of independence and thoughtful risk-taking within a compliance mindset. Its impact includes supporting the continued right to operate for marketed products.

Requirements

• 15+ years of relevant experience in the pharmaceutical, biotech, medical device or related industries, or at a major regulatory authority.
• Strong experience with regulatory and pharmaceutical policy.
• Inclusive, transformational and pragmatic leadership and change-management capabilities.
• Fluent English.
• Bachelor’s degree in a related science.

Nice To Haves

• Previous experience as an auditor, interfacing with regulatory authority inspectors, and/or in regulatory intelligence or advocacy.
• French-speaking ability.

Responsibilities

• Design, develop and implement the department roadmap.
• Lead risk-based auditing strategies, tactics and operations across GxP.
• Engage externally for intelligence, benchmarking and advocacy on critical Sanofi topics.
• Support routine and pre-approval regulatory inspection activities conducted by international regulators.
• Support due diligence and reverse due diligence activities.
• Use data and technology to drive efficiencies, enhance insights, facilitate knowledge sharing and simplify work.
• Represent Sanofi at key industry and trade association meetings and in working groups.
• Foster a culture of quality and cGMP compliance across organizational levels and drive continuous improvement.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employees may be eligible to participate in company employee benefit programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive