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Senior Manager, Quality Assurance Specialist

1 week ago


Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

Job Description:

  • This is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality systems.
  • The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (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.
  • The role includes 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, and leading Quality Risk Management activities on all Regeneron-sponsored clinical trials within assigned studies.
  • The ideal candidate will have advanced knowledge, understanding and application of GCP, and/or GVP guidelines including the management of significant/complex quality issues and compliance activities, as well as experience serving as a subject matter expert/process owner/business process owner in a quality related field/area.
  • To be considered 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).