Director, GPS Quality & Compliance

Role: Director of GPS Quality & Compliance at Regeneron, leading global quality event management and inspection readiness programs within the Patient Safety organization. Responsibilities: oversee inspection preparedness, serve as a primary contact during GCP and GVP audits, maintain inspection materials, translate regulatory requirements into actionable processes, and analyze quality metrics to inform leadership. Promote a culture of accountability and continuous improvement, and coordinate cross-functional teams. Requirements: Bachelor's degree (advanced degree preferred), 12+ years of pharmaceutical industry experience, with deep knowledge of PV regulations (FDA CFR, GVP Modules), and hands-on experience facilitating FDA/EMA inspections, particularly in GCP and GVP. Proven oversight of quality governance, metrics programs, and stakeholder management across departments such as Regulatory Affairs and QPPV. Preferred: healthcare professional background, people management experience. High-Value: extensive GxP, inspection readiness, global PV regulations, cross-functional leadership, and audit expertise. Work Setup: onsite in Warren, NJ (preferred), Armonk or Tarrytown, NY, or Cambridge, MA; 20% travel.