Senior Manager of Quality Assurance and Compliance

5 days ago


County Dublin, Ireland Regeneron Ireland Dac Full time

Key Responsibilities

This role involves leading and directing quality management initiatives across Global Development Quality (GDQ) systems.

The employee will provide guidance and leadership for all aspects of quality and compliance within GDQ, including risk-based quality management activities on all Regeneron-sponsored clinical trials.

This role requires collaborating with key stakeholders, building strategic partnerships, and working with study teams, relevant functions, and other GDQ functions.

The employee will manage GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team.

This role also involves 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.

This role requires engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system.

Participating in Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2.

Collaborating with Clinical Study Lead/Oversight Monitoring and CRO to monitor site level quality risks.

The ideal candidate will have a strong background in quality management, risk assessment/management, and providing GCP consultancy and support to internal and external stakeholders.

This role requires advanced knowledge and application of risk-based approaches to quality management and oversight, building fit-for-purpose quality processes in partnership with cross-functional teams and leaders.

For this opportunity, we are looking for: 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).

The ideal candidate will have a track record of success in leading quality management initiatives and improving processes.


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