Global Quality Auditor — Remote & International Compliance

Sanofi; Bridgewater Township (NJ); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Remote work option

Travel opportunities

Job summary

Sanofi is seeking a Global Quality Auditor to ensure compliance with cGMP, GDP, and regulatory requirements across manufacturing sites, suppliers, and affiliates worldwide. You will lead audits, support inspections, and drive CAPA programs with independence and strategic vision.

The role requires 5+ years in pharmaceutical quality auditing, travel up to 50%, fluent English, and ideally experience with FDA, EMA, and other major authorities.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 5+ years of quality auditing experience in pharma/biopharma.
• Strong cGMP knowledge and regulatory inspection experience.
• Ability to travel ~50% domestically and internationally.
• Excellent written and verbal communication in English; French is a plus.

Responsibilities

• Acts as lead auditor or co-auditor per Sanofi processes.
• Supports qualification of new auditors.
• Conducts transversal assessments across sites.
• Prepares and coaches entities for regulatory inspections (unannounced/short-notice).
• Participates in External Associations to stay current with trends.
• Evaluates entity risks and develops risk-based agendas and mitigations.
• Escalates critical issues and risks; approves CAPAs.
• Participates in Quality Governance Committees and cross-team audits.

Skills

Quality auditing

Regulatory understanding

Risk assessment

Leadership

Cross-functional collaboration

Education

Bachelor's degree in life sciences, pharmacy, engineering, or related field

Advanced degree (MSc, PharmD, PhD) preferred

Job description

Sanofi is seeking a Global Quality Auditor to ensure compliance with cGMP, GDP, and regulatory requirements across manufacturing sites, suppliers, and affiliates worldwide. You will lead audits, support inspections, and drive CAPA programs with independence and strategic vision.

The role requires 5+ years in pharmaceutical quality auditing, travel up to 50%, fluent English, and ideally experience with FDA, EMA, and other major authorities.