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: 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 master’s degree in science, pharmacy, engineering, data science, or equivalent with a minimum of 8 years relevant experience in the pharmaceutical, biotech, medical device, or related industries. Medical device experience is preferred.

• A minimum of 3 years of 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.)
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Languages

• Fluent French speaking and/or other languages is a plus

Preferred Qualifications

• Advanced degree (Masters or Doctorate) in science, pharmacy, engineering, data science, or equivalent

• Experience in domain that is being audited areas, with deep knowledge in one or two domains (e.g., Operational experience in Manufacturing, Medical Device, Computerized System, etc.).

• Previous experience as a Regulatory Authority Inspector.

• Member of International Society for Pharmaceutical Engineering (ISPE), BioPharma, BSI, and/or Parenteral Drug Association (PDA) with working group experience.

Soft and technical skills

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

• Familiar with Data Integrity, Data Privacy, and Cybersecurity requirements across GXPs (preferred)

• Strong command of regulatory requirements associated with scope of role

• 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.

• Proficiency in programming language(s) such as Python, JAVA, C++, R (preferred)

• Previous experience with international business travel.

  Excellent written and verbal communication skills to effectively present findings to diverse audiences. 

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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

$125,250.00 - $180,916.66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.