Senior Manager, GCP Quality & Risk (Hybrid)

Regeneron Pharmaceuticals, Inc; Armonk (NY); Hybrid; USD 134,000 - 219,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality management across clinical trials in a hybrid work model.

You will partner with study teams, CROs, and quality colleagues to drive risk assessment, control tracking, and issue resolution while supporting inspection readiness. The role emphasizes leadership, process improvement, and collaboration across global development quality functions to ensure patient safety

Qualifications

• Bachelor’s degree and eight years’ relevant healthcare or pharmaceutical industry experience.

Responsibilities

• Lead risk-based quality management across assigned clinical trials
• Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3
• Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis
• Partner with study leads, monitoring teams, and contract research organisations on site risks
• Escalate significant quality events and trends to Executive Quality Leadership
• Support inspection readiness, responses, and follow-up actions across relevant functions
• Manage onboarding, development goals, coaching, performance discussions, and team administration
• You champion quality, integrity, continuous learning, and trusted partnerships

Skills

Quality management

Risk assessment

Compliance

Inspection readiness

Staff management

Project management

Time management

Communication

Collaboration

Process improvement

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality management across clinical trials in a hybrid work model.

You will partner with study teams, CROs, and quality colleagues to drive risk assessment, control tracking, and issue resolution while supporting inspection readiness. The role emphasizes leadership, process improvement, and collaboration across global development quality functions to ensure patient safety