Director, GPS Quality & Inspection Readiness

Regeneron Pharmaceuticals; New Jersey; On-site; USD 183,000 - 305,000; Full time

Benefits offered by this job

On-site role

Job summary

Regeneron Pharmaceuticals is seeking a Director for GPS Quality & Compliance to drive quality event management and inspection readiness programs. Lead cross-functional teams, guide responses during GCP/GVP inspections, and maintain readiness materials while translating regulatory requirements into actionable steps.

You will champion a culture of accountability, analyze quality metrics, and present insights to senior leadership, with travel ~20% and on-site work in Warren, NJ or nearby locations.

Qualifications

• Bachelor's degree required; advanced degree preferred with 12+ years in pharma.
• Knowledge of global PV regulations and quality mgmt systems.
• Experience facilitating FDA/EMA inspections; POI experience.

Responsibilities

• Lead workstreams across quality event management and inspection programs.
• Serve as contact during GCP and GVP inspections; guide teams.
• Maintain inspection readiness materials and translate regulatory frameworks into action.
• Champion accountability and continuous improvement; escalation point for issues.
• Review quality metrics and trends to advise senior leadership.
• Present governance topics and quality insights to leadership.
• Coordinate across teams and functions beyond formal reporting lines.

Skills

Leadership

Quality systems

Inspection readiness

FDA inspections

GVP knowledge

Education

Bachelor's degree

Advanced degree preferred

Job description

Regeneron Pharmaceuticals is seeking a Director for GPS Quality & Compliance to drive quality event management and inspection readiness programs. Lead cross-functional teams, guide responses during GCP/GVP inspections, and maintain readiness materials while translating regulatory requirements into actionable steps.

You will champion a culture of accountability, analyze quality metrics, and present insights to senior leadership, with travel ~20% and on-site work in Warren, NJ or nearby locations.