Global Patient Safety & Quality Leader

Regulatory Jobs; New Jersey; On-site; USD 183,000 - 305,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron is seeking a Director, GPS Quality & Compliance to lead quality event management and inspection readiness within Global Patient Safety. Based in Warren, NJ, with 4 days on-site and travel up to 20%, you will partner with GDQ, QPPV Office, and Regulatory Affairs to drive governance and continuous improvement.

You will guide inspections (FDA/EMA), manage cross-functional teams, and translate regulatory frameworks into practical actions, delivering timely, data-driven insights to senior

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Deep knowledge of global PV regulations and GVP modules.
• Proven experience facilitating FDA/EMA inspections.
• Experience leading cross-functional teams and quality governance.

Responsibilities

• Lead quality event management and inspection programs across GPS.
• Coordinate teams and delegate work to ensure timely delivery.
• Support audits and inspections with preparation and real-time responses.
• Review metrics and trends to provide actionable leadership recommendations.
• Communicate governance topics clearly to senior leadership.

Skills

Quality governance

Regulatory inspections

Cross-functional leadership

data-driven decisions

Stakeholder communication

Education

Bachelor's degree

Advanced degree preferred

Job description

Regeneron is seeking a Director, GPS Quality & Compliance to lead quality event management and inspection readiness within Global Patient Safety. Based in Warren, NJ, with 4 days on-site and travel up to 20%, you will partner with GDQ, QPPV Office, and Regulatory Affairs to drive governance and continuous improvement.

You will guide inspections (FDA/EMA), manage cross-functional teams, and translate regulatory frameworks into practical actions, delivering timely, data-driven insights to senior