Global Quality Lead, GMP, GDP Audit and Inspection - Pipeline Launch

Job Title: Global Quality Lead, GMP, GDP Audit and Inspection - Pipeline Launch

Location: Framingham, MA or Morristown, NJ

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. 

• 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 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 qualification of new auditors, trains and coaches other auditors to share knowledge and facilitate development.

• 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., Pre-Approval Management Group, Inspection RISk and Compliance Council (IRISC), etc) as/when needed.

• Performs due diligence assessments, as/when needed.

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

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

• Contributes 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.  Serves as Deputy of Head of GMP/GDP Audit, Inspection – Pipeline, Launch Team.

• 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

Experience, Education, Soft Skills, Technical Skills, Languages

Basic Qualifications

• Minimum bachelor’s degree in science, pharmacy, engineering, data science, or equivalent with at least 10 years relevant experience in the pharmaceutical, biotech, medical device or a related industry or at a Regulatory agency with a focus on pharma/biotech.  

• At least five 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.

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