Senior Manager, GCP Quality & Risk Leader

Regeneron Pharmaceuticals, Inc.; Uxbridge; Hybrid; GBP 90,000 - 140,000; Full time

Benefits offered by this job

Bonus

Health benefits

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality across our clinical trials.

In a hybrid work model, you will partner with study teams, CROs, and Quality colleagues to ensure compliance with GCP and ICH guidelines while driving risk assessment and control activities. You will manage quality issues, audit responses, CAPAs, and trend analyses, mentor staff, and support inspection readiness across our global development

Qualifications

• Bachelor's degree and eight years' relevant healthcare or pharmaceutical industry experience
• Advanced knowledge of risk-based quality management and compliance
• Experience with regulatory inspections and inspection readiness
• Advanced Microsoft Office skills
• Strong communication and collaboration 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, CAPAs, preventive actions, and trend analysis
• Partner with study leads, monitoring teams, and CROs on site risks
• Escalate significant quality events and trends to Executive Quality Leadership
• Support inspection readiness, responses, and follow-up actions across relevant functions
• Champion quality, integrity, continuous learning, and trusted partnerships

Skills

risk-based quality management

risk assessment

compliance knowledge

audit responses & CAPA

communication & collaboration

process improvement

project management

MS Office

Education

Bachelor's degree

Job description

Regeneron Pharmaceuticals, Inc. seeks a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality across our clinical trials.

In a hybrid work model, you will partner with study teams, CROs, and Quality colleagues to ensure compliance with GCP and ICH guidelines while driving risk assessment and control activities. You will manage quality issues, audit responses, CAPAs, and trend analyses, mentor staff, and support inspection readiness across our global development