Sr Mgr GCP Quality

Tarrytown, New York, United States of America
Jul 15, 2021
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Senior Manager Quality Management Lead

The Regeneron GCP Quality Management Lead (QML) is a key position that will provide guidance and leadership for preparation and conduct of Regeneron-sponsored clinical trials from the time of synopsis generation and protocol authoring through final CSR. You will build strategic partnerships and direct risk-based quality management activities with Clinical Study Teams. Furthermore, we expect the QML will be responsible for assuring that the Clinical Study Team and all relevant documents are inspection ready at all times. The QML will partner with other members of the GCP Quality department to identify trends through metrics in order to diagnose and remediate systemic quality issues. S/he will also have responsibility for ensuring that no study "goes live" until all basic requirements are met (including but not limited to executed study plans and "live" systems (EDC, TMF, etc.)

In this role, a typical day might include the following:
  • Responsible for leading all aspects of 2-4 studies from a quality perspective within a program in conjunction with business and Associate Director/Director, QML
  • Lead Quality Risk Management activities on all Regeneron-sponsored clinical trials within assigned studies
  • Lead Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2
  • We review quality risks throughout the study and adjust the plan as necessary
  • Partner with Regeneron Clinical Study Lead/Oversight Monitoring/CRO to supervise site level quality risks
  • Participate as an active Clinical Study Team (CST) member
  • Provide day to day quality and compliance support to CST members, including SSN/issue management (investigation/actions), audit responses, proactive quality management, CAPA oversight, protocol deviation review, audit/protocol deviation/issue trending
  • Work with Associate Director and Director, GCP Quality Management Lead, to roll-up study information and trends
  • Collaborate with GCP Quality Inspection Management Team to assure that studies within assigned program are inspection ready at all times, including conduct of quality assessments, participation in site inspection readiness visits, and participation in inspection conduct
  • Perform periodic TMF reviews to assist teams in achieving a real-time approach to inspection readiness
  • Participate in Quarterly Quality Metrics Review
  • Supervise the study "Green Light" process assuring that no patient is entered into any clinical trial until all study level plans are approved and EDC, IxRS and ePRO have "gone live"

    This role might be for you if:
  • Bachelor's degree (Master's degree preferred) with 8+ years of relevant proven experience
  • We require 5+ years' experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.
  • We expect excellent interpersonal skills and ability to work with people in all levels of the organization and externally.
  • Demonstrated skills in taking initiative and working independently
  • Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
  • Demonstrated experience in driving Quality into the Clinical Trial Operations processes
  • Highly motivated with the ability to work effectively in a multifaceted environment with ambiguity
  • We seek someone with strong leadership with proven ability to collaborate with senior leaders
  • Good problem solving, written and verbal communication skills
  • Ability to effectively prioritize with a sense of urgency
  • Consistent track record of project management, partner management, collaboration skills and negotiation of sophisticated situations
  • Attention to detail and accuracy of work