Remote Global Quality Auditor – GxP Lead & Risk Expert

Regulatory Jobs; United States; À distance; USD 134 000 - 193 000; Plein temps

Résumé du poste

Sanofi Inc. in the United States is seeking a Global Quality Auditor to lead GxP audits across global quality.

The role emphasizes independence, risk-based auditing, and CAPA management, with collaboration across cross-functional teams to elevate audit effectiveness and compliance. The position requires five-plus years in GxP domains, strong knowledge of GCP/GVP, and a deep understanding of global regulatory standards; remote work is available within the US and international collaborations are

Qualifications

• BS/BA in Pharmacy, life sciences, engineering, or related field.
• Minimum 5+ years of experience in GxP domains (GCP or GVP).
• Knowledge of global regulatory requirements and standards.

Responsabilités

• Covers all GXP audit in GCP and GVP areas.
• Acts as lead auditor or co-auditor per Sanofi processes.
• Conducts transversal assessments and reviews audit reports.
• Evaluates entity risks and develops risk-based agendas.
• Escalates critical issues and manages CAPAs.
• Participates in audits with Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
• Contributes to departmental QMS, training curricula, and standard agendas.

Connaissances

Leadership

Risk Assessment

Communication

Independence

Compliance Mindset

Adaptability

Formation

Bachelor's degree in Pharmacy or life sciences

Description du poste

Sanofi Inc. in the United States is seeking a Global Quality Auditor to lead GxP audits across global quality.

The role emphasizes independence, risk-based auditing, and CAPA management, with collaboration across cross-functional teams to elevate audit effectiveness and compliance. The position requires five-plus years in GxP domains, strong knowledge of GCP/GVP, and a deep understanding of global regulatory standards; remote work is available within the US and international collaborations are