Global Quality Auditor: Lead GxP & Risk-Based Audits

BioSpace; Morristown (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Sanofi is seeking a Global Quality Auditor in Morristown, NJ to drive GXP audits across GCP and GVP within a global quality framework. You will act as a lead or co-auditor, shaping agendas and reviewing CAPA actions to ensure ongoing regulatory compliance.

The role emphasizes independent, proactive risk-based auditing, collaboration with cross-functional teams, and potential contributions to QMS and training materials. A strong background in life sciences is required.

Qualifications

• 5+ years of experience in GxP domains (GCP/GVP).
• BS or BA in Pharmacy, Life Sciences, Engineering, or related field.

Responsibilities

• Covers all GXP audit areas including GCP and GVP.
• Acts as lead auditor or co-auditor per Sanofi processes.
• Conducts transversal assessments.
• Reviews audit reports and contributes to CAPAs.
• Evaluates entity risks and develops risk-based agendas.
• Escalates critical issues and risks.
• Participates in audits with other Sanofi Quality teams.
• May help create QMS documents and training curricula.

Skills

GxP Knowledge

Audit Leadership

Cross-functional

Education

BSc/BA Life Sciences

Job description

Sanofi is seeking a Global Quality Auditor in Morristown, NJ to drive GXP audits across GCP and GVP within a global quality framework. You will act as a lead or co-auditor, shaping agendas and reviewing CAPA actions to ensure ongoing regulatory compliance.

The role emphasizes independent, proactive risk-based auditing, collaboration with cross-functional teams, and potential contributions to QMS and training materials. A strong background in life sciences is required.