Senior Manager GCP Quality
Regeneron · Dublin
QualityFull-timeCompany career page
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What they're looking for
- Bachelor's degree with eight years' pharmaceutical or healthcare industry experience
- Expertise in quality, clinical development, Good Clinical Practice, and regulatory compliance
- Advanced knowledge of risk-based quality management and risk assessment methodologies
- Demonstrated experience managing regulatory inspections and inspection readiness
- Staff management, training, and subject matter expertise capabilities
- Proficiency with Microsoft Office suite and strong communication skills
What you'll be doing
- Lead risk-based quality management across assigned clinical trial programs
- Conduct Quality Risk Assessments and manage control activities per ICH E6 R3
- Handle quality issues, audit responses, corrective and preventive actions, and trend analysis
- Collaborate with study teams, monitoring groups, and contract research organizations on site risks
- Manage team onboarding, performance discussions, and development of direct reports
Compensation€86,800–€141,200 annually
Privacy & handoff
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