Senior Manager, GCP Quality & Global Development

Regeneron; Uxbridge; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Regeneron seeks a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality oversight across global clinical trials. Hybrid work model with collaboration across study teams, CROs, and quality colleagues to ensure inspection readiness and robust compliance.

The role emphasizes team leadership, coaching, and continuous improvement to support Regeneron's fast-growing global development portfolio and patient impact.

Qualifications

• Bachelor's degree and eight years' healthcare or pharmaceutical industry experience.
• Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience.
• Advanced risk-based quality management, risk assessment, and compliance knowledge.
• Experience managing complex issues, regulatory inspections, and inspection readiness.
• Subject matter expert, process owner, training, presentation, and staff management experience.
• Process improvement, project management, prioritisation, and time management skills.
• Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills.

Responsibilities

• Lead risk-based quality management across 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 management

Regulatory compliance

Team management

Process improvement

Training & coaching

Project management

Time management

Education

Bachelor's degree

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Regeneron seeks a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality oversight across global clinical trials. Hybrid work model with collaboration across study teams, CROs, and quality colleagues to ensure inspection readiness and robust compliance.

The role emphasizes team leadership, coaching, and continuous improvement to support Regeneron's fast-growing global development portfolio and patient impact.