Global Head of Quality and External Assurance (Remote)

Sanofi Group; Cambridge, Morristown (MA, NJ); Remote; USD 180,000 - 240,000; Full time

Job summary

Sanofi seeks a Global Head of Quality Audit and External Liaison to lead risk-based audits, external engagement, and regulatory inspections across GXP domains. You will design the department roadmap, drive data-enabled improvements, and ensure cGMP compliance globally.

This senior role coordinates Manufacturing & Supply, R&D, Digital and Pharmacovigilance, influencing Sanofi’s quality posture across multiple regions, with independent action and global stakeholder collaboration.

Qualifications

• 15+ years relevant experience in the pharmaceutical, biotech, medical device, or related industries or a major regulatory authority.
• Fluent English.
• Bachelor's degree in a related science required.

Responsibilities

• 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.

Skills

Fluent English

Transformational leadership

Regulatory auditing

Strategic thinking

Education

Bachelor's degree in a related science

Job description

Sanofi seeks a Global Head of Quality Audit and External Liaison to lead risk-based audits, external engagement, and regulatory inspections across GXP domains. You will design the department roadmap, drive data-enabled improvements, and ensure cGMP compliance globally.

This senior role coordinates Manufacturing & Supply, R&D, Digital and Pharmacovigilance, influencing Sanofi’s quality posture across multiple regions, with independent action and global stakeholder collaboration.