Senior Manager GCP Quality
About The Position
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.
Requirements
- 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
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
Benefits
- 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
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
