Global Patient Safety: Quality & Compliance Director

Regeneron Pharmaceuticals Inc.

Armonk (NY)

On-site

USD 183,000 - 305,000

Full time

3 days ago
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Job summary

Regeneron Pharmaceuticals Inc. seeks a Director, GPS Quality & Compliance to lead quality event management and inspection readiness initiatives within our Global Patient Safety (GPS) group.

You will partner with senior leaders to ensure rigorous governance, timely responses to audits, and continuous improvement across cross-functional teams. In this role, you will translate regulatory requirements into actionable programs, manage relationships with GDQ, QPPV Office, and Regulatory Affairs, and

Qualifications

  • Bachelor's degree required; advanced degree preferred.
  • 12+ years in the pharmaceutical industry.
  • Deep knowledge of global PV regulations and GVP/GCP.
  • Experience leading FDA/EMA/MHRA inspections.
  • Proven governance and metrics programs oversight.

Responsibilities

  • Lead quality event management and inspection programs.
  • Coordinate and delegate across GPS team.
  • Serve as inspection contact during audits.
  • Maintain inspection readiness materials and regulatory frameworks.
  • Present governance topics to senior leadership.

Skills

Quality management
Regulatory inspections
Cross-functional leadership
GxP knowledge
Audit readiness

Education

Bachelor's degree
Advanced degree preferred

Job description

Regeneron Pharmaceuticals Inc. seeks a Director, GPS Quality & Compliance to lead quality event management and inspection readiness initiatives within our Global Patient Safety (GPS) group.

You will partner with senior leaders to ensure rigorous governance, timely responses to audits, and continuous improvement across cross-functional teams. In this role, you will translate regulatory requirements into actionable programs, manage relationships with GDQ, QPPV Office, and Regulatory Affairs, and

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