Director, GPS Quality & Compliance — Audit & Readiness

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 183,000 - 305,000; Full time

Benefits offered by this job

Annual bonuses or other incentivePlans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, v

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc is seeking a Director for GPS Quality & Compliance to lead quality event management and inspection readiness programs. You will partner with GPS leadership and Global Development Quality to ensure high-quality program delivery, guiding teams through GCP/GVP audits and regulatory readiness.

The role emphasizes data-driven insights, escalation leadership, and cross-functional collaboration across GDQ, QPPV Office, Regulatory Affairs, and vendors.

Qualifications

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

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.
• Translate regulatory frameworks into practical action and maintain inspection readiness materials.
• Champion accountability and continuous improvement, acting as an escalation point when issues arise.
• Review quality metrics and trend analyses to shape clear, actionable recommendations for senior leadership.
• Present governance topics and quality insights to senior team members with confidence and clarity.
• Lead through influence, coordinating across teams and functions regardless of formal reporting lines.

Skills

Quality event management

Inspection readiness

GCP/GVP audits

Cross-functional collaboration

Analytics & metrics

Education

Bachelor's degree

Advanced degree preferred

Tools

FDA CFR

GVP Modules

QMP governance

Job description

Regeneron Pharmaceuticals, Inc is seeking a Director for GPS Quality & Compliance to lead quality event management and inspection readiness programs. You will partner with GPS leadership and Global Development Quality to ensure high-quality program delivery, guiding teams through GCP/GVP audits and regulatory readiness.

The role emphasizes data-driven insights, escalation leadership, and cross-functional collaboration across GDQ, QPPV Office, Regulatory Affairs, and vendors.