Global Quality Auditor

Job Title: Global Quality Auditor

• Location: Morristown, NJ ,Remote

About the Job

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.

Foster best-in-class performance by leveraging data, technology and diverse talents to support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise.

This critical role:

• Covers all commercial activities.
• Covers Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP).
• Supports Sanofi’s Diverse product portfolio across all GBUs; Specialty Care, Vaccines, General Medicines. Internal and External Auditing (e.g., CMOs, Opella CHC, etc.) and Regulatory Inspections.
• Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products Administration (China), PMDA (Japan), ANVISA (Brazil).

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.

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 lives.

Main Responsibilities

• Acts as a lead auditor or co-auditor, in accordance with Sanofi processes.
• Supports qualification of new auditors.
• Conducts transversal assessments.
• Prepares, coaches, and supports entities for Regulatory Inspections through varying methods such as unannounced or short-notice visits.
• Participates in External Associations to stay current with emerging trends.
• Evaluates entity risks by developing targeted risk-based agendas and/or advise on mitigations.
• Escalates critical issues and risks.
• Approves/manages CAPAs.
• Participates in Quality Governance Committees (e.g., IRISC) as/when needed.
• Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy as needed.
• May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents.
• Management: No direct reports. May lead cross-functional teams for initiatives or projects.
• 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 role in transforming the practice of auditing in Sanofi.
• Scope: Manufacturing & Supply, Research & Development, Country Offices, Digital, Global Quality organizations in Sanofi, and third parties outside of Sanofi (e.g., Alliance Partners, CMOs, Strategic Vendors, etc.).

About You

Basic Qualifications

• Bachelor’s degree in relevant degree in life sciences, pharmacy, engineering, or any field; advanced degree (MSc, PharmD, PhD) preferred.
• 5+ years' experience in quality auditing preferably within the pharmaceutical or biopharma industry.

Preferred Qualifications:

• Strong track record in cGMP environments, regulatory inspection support, and risk-based audit methodologies.
• In-depth knowledge of international regulatory requirements and major health authorities including US FDA, EMA, ANSM, NMPA, PMDA, and ANVISA; proficiency in audit methodologies, CAPA management, and risk assessment frameworks.
• Highly independent and self-directed, with a strong compliance mindset and the ability to think creatively while taking thoughtful, calculated risks
• Demonstrated leadership capabilities and cross-functional collaboration skills.
• Willingness and ability to travel domestically and internationally (on average approximately 50%).
• Fluent written and spoken English, for Europe-based role French-speaking preferred.
• Excellent written and verbal communication skills, with the ability to convey complex compliance matters clearly to diverse audiences including site teams and senior leadership.
• Strong analytical and problem-solving capabilities to detect evolving trends and leverage data and metrics to assess quality system effectiveness against governing requirements.

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 lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

…