Remote Global Quality Auditor - GxP & Compliance Lead

Sanofi

Northern (KY)

Hybrid

USD 90,000 - 140,000

Full time

3 days ago
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Benefits offered by this job

Health benefits
Wellness programs
Parental leave (14 weeks)

Job summary

Sanofi seeks a Global Quality Auditor to support remote audits across the US. You will lead or co-lead GXP, GCP, and GVP reviews within a global quality network, ensuring risk-based audit plans and timely CAPA closures.

You’ll partner with cross-functional teams to uphold regulatory standards, drive continuous improvement, and transform auditing practices for Sanofi’s manufacturing and supply chain operations.

Qualifications

  • 5+ years in GxP, GCP, or GVP domains.
  • Experience leading audits or co-audits within a global QA framework.
  • Knowledge of regulatory requirements and QMS concepts.

Responsibilities

  • Covers GXP audits in current GCP and GVP areas.
  • Acts as lead auditor or co-auditor per Sanofi processes.
  • Performs transversal assessments and reviews audit reports.
  • Evaluates entity risks and recommends mitigations.
  • Escalates critical issues and approves CAPAs.
  • Participates in audits with QA, Inspection, and Intelligence teams.
  • Contributes to departmental QMS and training curricula.

Skills

Leadership
Risk assessment
Communication
Independence
Compliance mindset
Adaptability

Education

BS or BA in Pharmacy, Life Sciences, Engineering, or related

Job description

Sanofi seeks a Global Quality Auditor to support remote audits across the US. You will lead or co-lead GXP, GCP, and GVP reviews within a global quality network, ensuring risk-based audit plans and timely CAPA closures.

You’ll partner with cross-functional teams to uphold regulatory standards, drive continuous improvement, and transform auditing practices for Sanofi’s manufacturing and supply chain operations.

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