Global Head of Quality, Audit, & Regulatory Intelligence

Sanofi Group; New Jersey; On-site; USD 220,000 - 300,000; Full time

Job summary

Sanofi seeks a Global Head of Quality Audit Inspection & Intelligence Advocacy to lead risk-based auditing across GXP domains and drive regulatory inspection activities. You will shape the department roadmap, engage with regulators, and promote data-driven quality improvements across Manufacturing & Supply, R&D, Digital, PV and Commercial.

Strong leadership with 15+ years in pharma, excellent English, and a track record in advocacy and regulatory interfaces are essential for this strategic role

Qualifications

• 15+ years relevant experience in pharma, biotech, medical devices, or related sectors or major regulatory authority.
• Inclusive, transformational, pragmatic leadership and change management. Fluent English.

Responsibilities

• Design, develop and implement the department roadmap.
• Lead risk-based auditing strategies across GXP and engage external intelligence and advocacy.
• Oversee Regulatory Inspection Activities (routine and Pre-Approval Inspections).
• Support due diligence and reverse due diligence activities.
• Utilize data and technology to drive efficiencies and insights.
• Represent Sanofi at industry meetings and working groups.
• Foster a culture of quality and cGMP compliance across the organization.

Skills

Regulatory auditing

Leadership

Risk-based thinking

Fluent English

Education

Bachelor's degree in science or related field

Job description

Sanofi seeks a Global Head of Quality Audit Inspection & Intelligence Advocacy to lead risk-based auditing across GXP domains and drive regulatory inspection activities. You will shape the department roadmap, engage with regulators, and promote data-driven quality improvements across Manufacturing & Supply, R&D, Digital, PV and Commercial.

Strong leadership with 15+ years in pharma, excellent English, and a track record in advocacy and regulatory interfaces are essential for this strategic role