Sanofi
Biopharma
GlobalQualityAuditor
Neural analysis suggests this role is
optimal for Senior candidates.
“Global Quality Auditor at Sanofi. Skills: Quality Audit, Risk Management, Regulatory Compliance. Cover GXP audits. Act as lead auditor”
What You'll Achieve.
Detect evolving trends; Adjust audit strategy; Adjust inspection tactics; Transform auditing practice
Industry & Context.
Creative problem-solving
What They're Looking For.
Must Have
BS or BA degree, 5+ years GxP experience, Deep knowledge regulatory requirements, Understanding quality management systems
Nice to Have
Leadership skills, Risk assessment expertise, Excellent communication skills, Creative problem-solving abilities, Ethical foundation, Adaptability to trends
What You'll Do.
Conduct transversal assessments
Contribute to team scheduling
Approve audit reports
Evaluate entity risks
Develop risk-based agendas
Advise on mitigations
Escalate critical issues
Perform due diligence assessments
Participate in audits
Participate in activities
Contribute to QMS creation
Detect evolving trends
Adjust audit strategy
Adjust inspection tactics
How You'll Work.
Team & Collaboration
Global Quality organizations; Country organization; Third parties; Strategic Vendors; Other teams
Communication Scope
Written communication; Verbal communication
Full Job Description
**Job Title** : Global Quality Auditor * Location: Morristown, NJ **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 Sc
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