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Global Quality Management Expert
1 week ago
Overview
The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) plays a pivotal role in providing guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. As a key position, this individual will engage with stakeholders, build strategic partnerships, and work closely with study teams and functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials.
This is a hybrid position that requires 3 days of on-site work. A typical day may include acting as a Subject Matter Expert (SME) and liaison to GDQ, providing support and advice on quality issues to ensure compliance and facilitate the Quality Risk Assessment process.
Key responsibilities include ensuring and managing GCP-compliant activities from a quality perspective, collaborating with other functional areas to drive Risk-Based Quality Management (RBQM) initiatives and process improvements, and providing day-to-day quality and compliance support to cross-functional stakeholders. This includes issue management, audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending, and engaging with multiple stakeholders whose work impacts the GDQ system.
The ideal candidate will possess advanced knowledge, understanding, and application of GCP and/or GVP guidelines, including managing significant/complex quality issues and compliance activities. Additionally, they will have experience serving as a subject matter expert/process owner/business process owner in a quality-related field/area, providing training and presenting information on key quality and regulatory compliance topics.
