Global Quality Auditor

Sanofi; Morristown (NJ); Remote; USD 134,000 - 193,000; Full time

Benefits offered by this job

Parental leave (14 weeks)

Health and wellbeing benefits

Competitive rewards package

Job summary

Sanofi is seeking a Global Quality Auditor available for remote work within the United States. This role supports the Manufacturing & Supply network, conducting audits across GXP domains, leading or co-auditing, and driving risk-based audit programs.

You will assess entity risks, approve CAPAs, and collaborate with the Quality Audit, Inspection, Intelligence & Advocacy teams. A BS/BA in relevant field and 5+ years in GxP, GCP or GVP domains are required, with strong QMS knowledge and

Qualifications

• BS/BA in Pharmacy, Life Sciences, Engineering or related field; will consider all degrees.
• Minimum 5+ years of extensive experience in GxP domains, GCP or GVP.
• Deep knowledge of global regulatory requirements and standards.
• Strong understanding of quality management systems (QMS).
• Leadership to guide cross-functional teams and initiatives.
• Risk assessment expertise to identify and mitigate quality risks.
• Excellent written and verbal communication.

Responsibilities

• Covers all GXP audit in areas of current, GCP, GVP.
• Acts as a lead auditor or co-auditor per Sanofi processes.
• Conducts transversal assessments across functions.
• Reviews audit reports and supports team scheduling.
• Evaluates entity risks and advises on mitigations.
• Escalates critical issues and risks promptly.
• Approves or manages CAPAs and corrective actions.
• Performs due diligence assessments as needed.
• Collaborates with Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
• Contributes to QMS documents and training curricula.

Skills

GxP knowledge

QMS understanding

Leadership

Risk assessment

Communication skills

Independent work

Compliance mindset

Adaptability

Education

BS/BA in Pharmacy, Life Sciences, Engineering

Job description

Job Title: Global Quality Auditor Location: Remote within US

About the Job

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• Covers all GXP audit in areas of current, Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP).
• Acts as a lead auditor or co-auditor, in accordance with Sanofi processes.
• Conducts transversal assessments.
• 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.
• Performs due diligence assessments, as/when needed.
• Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
• May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents.
• 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

Global Quality organizations in Sanofi, country organization, and third parties outside of Sanofi (e.g. Strategic Vendors, etc.)

About You

Basic Qualifications: BS or BA degree in Pharmacy, Life Sciences, Engineering, or related, but will consider all degrees. Minimum 5+ years of extensive experience in GxP domains, Good Pharmacovigilance Practices, or Good Clinical Practices.

• Deep knowledge of global regulatory requirements and standards.
• Strong understanding of quality management systems (QMS).
• Leadership Skills: Ability to lead cross-functional teams and initiatives.
• Risk Assessment: Expertise in evaluating and mitigating quality risks.
• Communication: Excellent written and verbal communication skills.
• Independence: Highly independent with creative problem-solving abilities.
• Compliance Mindset: Strong ethical foundation with thoughtful risk-taking approach.
• Adaptability: Ability to detect evolving trends and adjust strategies accordingly.

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. Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply. Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

• 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 andwellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affid...

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

North America Applicants Only

The salary range for this position is: $133,500.00 - $192,833.33

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.

We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.