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Senior Manager, GD Quality Management

4 months ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The GDQM (GCP) QML will engage with key stakeholders, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness.

A day in the life may look like:


• Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process.

• Ensuring and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas.

• 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.

• 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 E6 R2.

This may be the right role for you if you have experience:


• Providing consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines.

• Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process.

• Supporting the collection and reporting of data (e.g., metrics).

• Contributing to and supporting process improvement initiatives and workgroups, as assigned.

• Exemplifying a quality mindset and behaviors in all interactions with internal and external colleagues, serving as an ambassador for GDQ.

In order to be considered for this role, we are looking for candidates who have:

• Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience.

• Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP).