Global Head of Quality, Audit & Regulatory Intelligence

Sanofi

Morristown (NJ)

On-site

USD 250,000 - 380,000

Full time

4 days ago

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Job summary

Sanofi is seeking a Global Head of Quality Audit Inspection & Intelligence Advocacy to lead risk-based auditing and external regulatory engagement across GXP. The role prioritizes inspector readiness, data-driven insights, and advocacy for critical quality topics.

The position can be based in Cambridge, MA or Morristown, NJ and will drive the department roadmap, collaborate with Manufacturing & Supply, R&D, Digital, and Pharmacovigilance, and champion continuous improvement across the

Qualifications

15+ years of relevant experience in pharmaceutical, biotech, medical device, or related industries.
Inclusive, transformational leadership and change management; fluent English.
Bachelor's degree in a related science.

Responsibilities

Design, develop and implement the department roadmap.
Risk-based auditing strategies across GXP; engage externally for intelligence and benchmarking, and advocacy for Sanofi topics.
Regulatory inspection activities for routine and Pre-Approval Inspections by international regulators.
Support due diligence and reverse due diligence activities.
Utilize data and technology to drive efficiencies, enhance insights, and knowledge sharing.
Represent Sanofi at external meetings and working groups.
Foster a culture of quality and cGMP compliance across the organization.
Operate with high independence and strategic risk-taking mindset to ensure continued right to operate for marketed products.