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 +12 years relevant experience in the pharmaceutical, biotech, medical device, or related industries.
• 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.
• Familiar with Data Integrity, Data Privacy, and Cybersecurity requirements across GXPs.
• Ability to interpret complex data, identify key trends, and draw meaningful conclusions.
• Robust knowledge of current international regulations relevant to scope of auditing, inspection domain, including practical application in a complex regulatory environment.
• Previous experience with international business travel of ~50%.
• Excellent written and verbal communication skills to effectively present findings to diverse audiences.
• Fluent English.
  
  

Preferred Qualifications

• Advanced degree (Masters or Doctorate) in science, pharmacy, engineering, data science, or equivalent
• Experience preparing for and direct support of US FDA GMP Pre-Approval Inspections, and follow up activities (e.g., inspection response process, complete response letters (CRLs), post-application action letters (PAAL), information requests (IRs), etc.)
• Experience in domain that is being audited areas, with deep knowledge in one or two domains (e.g., Operational experience in Clinical, Pharmacovigilance, Manufacturing, Site Quality Head for a Manufacturing Site, etc.).
• Previous experience as a Regulatory Authority Inspector.
• Member of International Society for Pharmaceutical Engineering (ISPE), BioPhorum, BSI, and/or Parenteral Drug Association (PDA) with working group experience.
• French speaking and/or other languages is a plus.
  
  

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.
• 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; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.