Senior Manager GCP Quality
$134.4k - $219.2kRegeneron Pharmaceuticals, Inc.
Responsibilities
- Lead risk-based quality management across assigned clinical trials
- Drive Quality Risk Assessment and Control Tracker activities under ICH E6 R3
- Manage quality issues, audit responses, corrective actions, and trend analysis
- Partner with study leads and contract research organizations on site risks
- Support inspection readiness, responses, and follow-up actions across functions
Requirements
- Bachelor's degree and eight years healthcare or pharmaceutical industry experience
- Quality, compliance, clinical development, GCP, or GPvP expertise
- Advanced risk-based quality management and risk assessment knowledge
- Experience managing complex issues, regulatory inspections, and inspection readiness
- Subject matter expertise, process ownership, training, and staff management capability
- Process improvement and project management skills with strong prioritization ability
- Advanced proficiency in Microsoft Outlook, Word, Excel, and PowerPoint
Compensation: $134,400-$219,200 annually
Vacancy posted 4 days ago
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