Global Quality Auditor

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

About The Job

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, you\'ll help reimagine how life-changing treatments reach people everywhere, faster

Job Title: Global Quality Auditor

Grade: L3-2

Hiring Manager: Zahra Brahimi

Location: Morristown, NJ

Main Responsibilities

• Covers all GXP audit in areas of current, Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP).
• Acts as a lead auditor or co-auditor, in accordance with Sanofi processes.
• Conducts transversal assessments.
• Contributes to team scheduling and reviews/approves audit reports for team members.
• Evaluates entity risks developing targeted risk-based agendas and/or advise on mitigations.
• Escalates critical issues and risks.
• Approves / manages CAPAs.
• Performs due diligence assessments, as/when needed.
• Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
• May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents.
• Latitude of action: Highly independent, creative with thoughtful risk taking and compliance mindset.
• Role impact: Able to detect evolving trends which will result in adjustment of Sanofi audit and inspection strategy and tactics. Plays a key role in transforming the practice of auditing in Sanofi.
• Scope: Global Quality organizations in Sanofi, country organization, and third parties outside of Sanofi (e.g. Strategic Vendors, etc.)

About You

Basic Qualifications:

• BS or BA degree in Pharmacy, Life Sciences, Engineering, or related, but will consider all degrees.
• Minimum 5+ years of extensive experience in GxP domains, Good Pharmacovigilance Practices, or Good Clinical Practices.

Preferred Qualifications

• Deep knowledge of global regulatory requirements and standards.
• Strong understanding of quality management systems (QMS).
• Leadership Skills: Ability to lead cross-functional teams and initiatives
• Risk Assessment: Expertise in evaluating and mitigating quality risks
• Communication: Excellent written and verbal communication skills
• Independence: Highly independent with creative problem-solving abilities
• Compliance Mindset: Strong ethical foundation with thoughtful risk-taking approach
• Adaptability: Ability to detect evolving trends and adjust strategies accordingly

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Equal Opportunity and Diversity

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG #vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.