Senior GCP Quality Lead, Global Development

Regeneron Pharmaceuticals, Inc; Dublin; Hybrid; EUR 87,000 - 141,000; 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 ensure inspection readiness and ongoing compliance while mentoring the team. The role requires a Bachelor’s degree with extensive healthcare or pharmaceutical industry experience, strong knowledge of GCP and regulatory inspections, and

Qualifications

• Lead risk-based quality management across clinical trials.
• Experience with ICH guidelines and GCP.
• Strong collaboration with study teams, CROs andQuality colleagues.

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 CROs on site risks.
• Escalate significant quality events to Executive Quality Leadership.
• Support inspection readiness, responses, and follow-up actions across functions.
• Manage onboarding, development goals, coaching, performance discussions, and team administration.
• You champion quality, integrity, continuous learning, and trusted partnerships.

Skills

Leadership

Quality management

Communication

Project management

Team coaching

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 ensure inspection readiness and ongoing compliance while mentoring the team. The role requires a Bachelor’s degree with extensive healthcare or pharmaceutical industry experience, strong knowledge of GCP and regulatory inspections, and