Global Quality Auditor

Sanofi•Morristown, NJ

1d•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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

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.