Senior Manager GCP Quality

$134.4k - $219.2k

Regeneron Pharmaceuticals, Inc.

Warren, MI

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

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Vacancy posted 24 days ago

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