Global Quality Auditor- GVP-GCP-GXP

Job Title: Global Quality Auditor- GVP-GCP-GXP

Location: Morristown, NJ

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.

Ensures that Sanofi Quality and Compliance Standards, and applicable regulatory authorities’ requirements are met and that all Sanofi sites, Operational Units, affiliates, and third parties achieve, maintain and improve the adequate level of compliance, through independent auditing and follow-up. Job Family Group: Quality - Audit

Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
 

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.

• Deep knowledge of global regulatory requirements and standards.

• Strong understanding of quality management systems (QMS).

Key Competencies

• 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 it’s through a promotion or a 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. 

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; affec