Global Quality Auditor — Remote (US)

Sanofi; Morristown (NJ); Remote; USD 134,000 - 193,000; Full time

Benefits offered by this job

Parental leave (14 weeks)

Health and wellbeing benefits

Competitive rewards package

Job summary

Sanofi is seeking a Global Quality Auditor available for remote work within the United States. This role supports the Manufacturing & Supply network, conducting audits across GXP domains, leading or co-auditing, and driving risk-based audit programs.

You will assess entity risks, approve CAPAs, and collaborate with the Quality Audit, Inspection, Intelligence & Advocacy teams. A BS/BA in relevant field and 5+ years in GxP, GCP or GVP domains are required, with strong QMS knowledge and

Qualifications

• BS/BA in Pharmacy, Life Sciences, Engineering or related field; will consider all degrees.
• Minimum 5+ years of extensive experience in GxP domains, GCP or GVP.
• Deep knowledge of global regulatory requirements and standards.
• Strong understanding of quality management systems (QMS).
• Leadership to guide cross-functional teams and initiatives.
• Risk assessment expertise to identify and mitigate quality risks.
• Excellent written and verbal communication.

Responsibilities

• Covers all GXP audit in areas of current, GCP, GVP.
• Acts as a lead auditor or co-auditor per Sanofi processes.
• Conducts transversal assessments across functions.
• Reviews audit reports and supports team scheduling.
• Evaluates entity risks and advises on mitigations.
• Escalates critical issues and risks promptly.
• Approves or manages CAPAs and corrective actions.
• Performs due diligence assessments as needed.
• Collaborates with Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
• Contributes to QMS documents and training curricula.

Skills

GxP knowledge

QMS understanding

Leadership

Risk assessment

Communication skills

Independent work

Compliance mindset

Adaptability

Education

BS/BA in Pharmacy, Life Sciences, Engineering

Job description

Sanofi is seeking a Global Quality Auditor available for remote work within the United States. This role supports the Manufacturing & Supply network, conducting audits across GXP domains, leading or co-auditing, and driving risk-based audit programs.

You will assess entity risks, approve CAPAs, and collaborate with the Quality Audit, Inspection, Intelligence & Advocacy teams. A BS/BA in relevant field and 5+ years in GxP, GCP or GVP domains are required, with strong QMS knowledge and