Senior Manager of Quality and Compliance

6 days ago


Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

In this critical role, you will be responsible for the management of 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, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending.

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You will engage with, support, and liaise with multiple cross-functional stakeholders whose work impacts the GDQ system. Leading Quality Risk Management activities on all Regeneron-sponsored clinical trials within assigned studies. Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2.



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