Global Quality Auditor

Job Title: Global Quality Auditor

Location: Morristown, NJ, Framingham, MA, Swiftwater, PA 

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.

This critical role:

• Covers all Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI to launch, and 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).

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 and supports 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: 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: Manufacturing & Supply, Research & Development, Countries, Digital, Global Quality organizations in Sanofi.  And third parties outside of Sanofi (e.g., Alliance Partners, CMOs, Strategic Vendors, etc.).

About You:

Basic Qualifications

• Minimum bachelor’s degree in science, pharmacy, engineering, data science, business or equivalent with at least 8 years relevant experience in the pharmaceutical, biotech, medical device, or related industries. 

• At least three years relevant experience as Quality Auditor.

• Direct experience preparing for and supporting Regulatory Inspections from Regulators (e.g., US FDA, ANSM, PMDA, NMPA, EMA, MHRA, etc.)

• Action oriented, results driven, performance and patient focused mindset.