Global Head of Quality, Audit & Intelligence Advocacy

Sanofi; Oregon; Híbrido; USD 248.000 - 358.000; Jornada completa

Descripción de la vacante

Sanofi in the United States is seeking a Global Head of Quality Audit Inspection & Intelligence Advocacy to drive risk-based audit programs, regulatory inspections, and analytic insights across GXP. This executive will lead with integrity, collaboration, and innovation to secure product launches and ongoing compliance.

You will shape the department roadmap, engage external regulators and industry groups, and leverage data and AI to improve efficiency and knowledge sharing across Manufacturing,

Formación

• 15+ years of relevant pharmaceutical/biotech/medical device experience or regulatory authority.
• Strong experience with regulatory and pharmaceutical policy.
• Bachelor's degree in a related science.
• Fluent English.

Responsabilidades

• Design, develop and implement the department roadmap.
• Risk-based auditing strategies, tactics, and operations across GXP.
• 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.

Conocimientos

Fluent English

Transformational leadership

Change management

Educación

Bachelor's degree in related science

Descripción del empleo

Sanofi in the United States is seeking a Global Head of Quality Audit Inspection & Intelligence Advocacy to drive risk-based audit programs, regulatory inspections, and analytic insights across GXP. This executive will lead with integrity, collaboration, and innovation to secure product launches and ongoing compliance.

You will shape the department roadmap, engage external regulators and industry groups, and leverage data and AI to improve efficiency and knowledge sharing across Manufacturing,