Global Head of Quality Assurance & Intelligence Advocacy

Sanofi; Cambridge (MA); On-site; USD 260,000 - 360,000; Full time

Job summary

Sanofi is seeking a Global Head of Quality Audit Inspection & Intelligence Advocacy in Cambridge, MA or Morristown, NJ. Lead risk-based audits, regulatory inspections, and advocacy across GXP, data-driven intelligence, and digital strategies to safeguard product quality and compliance.

You will drive cross-functional collaboration across Manufacturing, R&D, PV, and Commercial, shaping the quality agenda globally.

Qualifications

• 15+ years relevant experience in pharma, biotech, medical devices, or regulatory bodies.
• Strong experience with regulatory and pharmaceutical policy.

Responsibilities

• Design, develop and implement the department roadmap.
• Lead risk-based auditing strategies across GXP and external intelligence efforts.
• Manage Regulatory Inspection activities and pre-approval inspections.
• Support due diligence and reverse due diligence activities.
• Use data and digital tech to drive insights and knowledge sharing.
• Represent Sanofi at industry meetings and working groups.
• Foster a culture of quality and cGMP compliance across the organization.
• Operate with independence and a compliant risk-taking mindset.
• Scope includes Manufacturing, Supply, R&D, Digital, PV, and Commercial.

Skills

Fluent English

Transformational leadership

Change management

Cross-functional collaboration

Education

Bachelor's degree in related science

Job description

Sanofi is seeking a Global Head of Quality Audit Inspection & Intelligence Advocacy in Cambridge, MA or Morristown, NJ. Lead risk-based audits, regulatory inspections, and advocacy across GXP, data-driven intelligence, and digital strategies to safeguard product quality and compliance.

You will drive cross-functional collaboration across Manufacturing, R&D, PV, and Commercial, shaping the quality agenda globally.