Global Quality Auditor - Technology Audit and Inspection

Job title: Global Quality Auditor - Technology Audit and Inspection

Location: Morristown, NJ or Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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.  Grounded in core values Integrity, Collaboration, Innovation, Expertise.

Are you ready to shape the future of Quality Audits? As Global Quality Auditor - Technology Audit & Inspection at Sanofi, your mission would be to:

• Assess whether Sanofi's diverse technology solutions (medical devices, drug-device combinations, computerized systems, in vitro diagnostics (IVDs), radio pharma products, software as medical device (SaMDs) meet regulatory requirements and industry standards.

• Help develop and implement innovative approaches for auditing artificial intelligence systems, ensuring they meet quality, safety, and regulatory requirements while maintaining data integrity.

• Prepare for and assist during regulatory inspections related to technology systems, serving as a subject matter expert to address inspector questions and concerns.

• Execute audits based on the team's risk assessment methodology, focusing resources on highest-risk areas across Sanofi's global technology landscape.

• Identify opportunities to enhance quality systems and technological implementations, providing recommendations that balance innovation with compliance.

• Work with various stakeholders (R&D, Manufacturing, IT, Quality) to ensure technology implementations meet quality standards while supporting business objectives.

• Maintain expertise in evolving regulatory requirements for healthcare technologies, particularly emerging guidance on AI and software as medical devices.

This role represents the intersection of quality assurance, technological innovation, and regulatory compliance in a forward-thinking pharmaceutical environment.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Acts as a lead auditor or co-auditor, in accordance with Sanofi processes.

• Facilitates qualification of new auditors.

• Conducts transversal assessments.

• Prepares, coaches, and supports entities for Regulatory Inspections through varying methods such as Mock Inspections, unannounced or short-notice visits, etc. 

• Participates in External Associations to stay current with emerging trends.

• 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.

• Participates in Quality Governance Committees (e.g., PMG, IRISC, etc.) as/when needed.

• May perform due diligence assessments, as/when needed.

• Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy.

• May collaborate within Sanofi Quality Audit, Inspection, Intelligence & Advocacy department team members for Insight Generation.

• 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: