Global Quality Auditor - Remote & International Compliance

Sanofi

United States

Hybrid

USD 134,000 - 193,000

Full time

2 days ago
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Job summary

Sanofi in Morristown, NJ seeks a Global Quality Auditor to ensure compliance with cGMP and regulatory requirements across Sanofi sites and third parties, including US FDA and international authorities. The role covers Manufacturing & Supply andRegulatory inspections, audits and follow-ups, with a focus on cross‑functional collaboration.

You will lead audits, manage CAPAs, and support regulatory inspections while traveling domestically and internationally as needed.

Qualifications

  • Bachelor’s degree in life sciences, pharmacy, engineering, or related field.
  • 5+ years of quality auditing experience in pharma/biopharma.
  • Knowledge of cGMP and regulatory inspections.
  • Experience with international regulatory authorities (FDA, EMA, etc.).
  • Fluency in English; French skills preferred for Europe-based roles.

Responsibilities

  • Lead or co-audit Sanofi sites and external partners.
  • Support regulatory inspections and CAPA processes.
  • Develop risk-based audit plans and agendas.
  • Coach and qualify new auditors.
  • Collaborate with Quality Audit, Inspection, Intelligence & Advocacy teams.

Skills

Quality auditing
cGMP knowledge
Regulatory inspections
English proficiency
Travel readiness

Education

Bachelor’s degree in life sciences/pharmacy/engineering
Advanced degree (MSc/PharmD/PhD) preferred

Job description

Sanofi in Morristown, NJ seeks a Global Quality Auditor to ensure compliance with cGMP and regulatory requirements across Sanofi sites and third parties, including US FDA and international authorities. The role covers Manufacturing & Supply andRegulatory inspections, audits and follow-ups, with a focus on cross‑functional collaboration.

You will lead audits, manage CAPAs, and support regulatory inspections while traveling domestically and internationally as needed.

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