Director, GPS Quality & Compliance

The Global Patient Safety (GPS) organization at Regeneron is seeking a Director, GPS Quality & Compliance to support quality event management and inspection readiness programs. This role partners closely with the Senior Director, GPS leadership, Global Development Quality, and the QPPV Office, and operates as a functional leader who coordinates and delegates work across the team to ensure consistent, high-quality program delivery.

About the role

• Lead functional workstreams across quality event management and inspection programs, coordinating and delegating work across a team
• Serve as a trusted point of contact during GCP and GVP audits and inspections, guiding teams through preparation and real-time response
• Bring order to complexity by maintaining inspection readiness materials and translating regulatory frameworks into practical action
• Champion a culture of accountability and continuous improvement, acting as an escalation point when issues arise
• Communicate with confidence and clarity, presenting governance topics and quality insights to senior team members
• Lead through influence, coordinating across teams and functions regardless of formal reporting lines

Responsibilities

• Lead functional workstreams across quality event management and inspection programs, coordinating and delegating work across a team
• Serve as a trusted point of contact during GCP and GVP audits and inspections, guiding teams through preparation and real-time response
• Bring order to complexity by maintaining inspection readiness materials and translating regulatory frameworks into practical action
• Champion a culture of accountability and continuous improvement, acting as an escalation point when issues arise
• Communicate with confidence and clarity, presenting governance topics and quality insights to senior team members
• Lead through influence, coordinating across teams and functions regardless of formal reporting lines

Requirements

• Bachelor's degree required; advanced degree preferred with a minimum of 12 years of pharmaceutical industry experience; Healthcare Professional background preferred
• Deep knowledge of global PV regulations, quality management systems, and inspection readiness frameworks (FDA CFR, GVP Modules)
• Demonstrated experience facilitating FDA and EMA/MHRA inspections (GCP and GVP), including direct experience as an inspection point of contact
• Prominent track record overseeing QMP governance, metrics programs, and cross-functional quality oversight
• Experience managing relationships across GDQ, QPPV Office, Regulatory Affairs, and vendors

Qualifications

• People management experience preferred

Skills

• Strong communication and interpersonal skills
• Ability to manage multiple priorities and deadlines
• Excellent organizational and project management skills
• Strong analytical and problem-solving abilities

Benefits

• Comprehensive total rewards package including annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits

Pay

$183,100.00 - $305,200.00 annually

Schedule

4 days/week on-site

Travel

20%