Sr Mgr GD Quality Management

Role Summary

The Senior Manager, Global Development Quality Management (GCP) acts as a Quality Management Lead (QML) and provides guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The GDQM (GCP) QML engages with key stakeholders, builds strategic partnerships with study teams and cross-functional GDQ groups to lead risk-based quality management activities on Regeneron-sponsored clinical trials, including issue management and ongoing inspection readiness support. Location-specific on-site expectations apply: US locations (Armonk, NY or Warren, NJ) require on-site 4 days per week with 1 day remote; UK (Uxbridge) or Ireland (Dublin) require on-site 3 days per week with 2 days remote; fully remote is not available.

Responsibilities

• Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advice on quality issues to ensure compliance and support the Quality Risk Assessment process.
• Ensuring and driving Risk-Based Quality Management (RBQM) initiatives and process improvements in partnership with other functional areas.
• Managing GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team.
• Providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage, investigation, actions), audit responses, proactive quality management, CAPA oversight, and audit/issue trending.
• Engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system.
• Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH-GCP.

Qualifications

• Preferred: Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience.
• Preferred: Experience in quality/compliance roles (e.g., Quality Management, Quality Assurance) or in Clinical Development with expertise related to Good Clinical Practice (GCP) and/or Good Pharmacovigilance Practice (GVP).
• Preferred: Providing consultation, mentorship, training, and support for compliance with international regulations, practices, and guidelines.
• Preferred: Advising on escalation of quality issues that may represent serious non-compliances via the escalation process.
• Preferred: Supporting data collection and reporting (e.g., metrics).
• Preferred: Contributing to and supporting process improvement initiatives and cross-functional workgroups.
• Preferred: Demonstrating a quality mindset in all interactions and acting as an ambassador for GDQ.

Education

• Bachelor's degree (any field).

Additional Requirements

• On-site requirements by location: US-based roles (Armonk, NY or Warren, NJ) require on-site presence 4 days per week with 1 day remote; UK (Uxbridge) or Ireland (Dublin) require on-site 3 days per week with 2 days remote; fully remote arrangements are not available for this position.