Senior Manager GCP Quality

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

• 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
• Bachelor's degree and eight years' relevant 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
• Strong communication, collaboration
• At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
• Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.
• If you have any questions, please speak with your recruiter.