Sanofi

Biopharma

GlobalQualityAuditor

$134–193k Morristown, New Jersey, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Biopharma
Problems you'll solve

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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