Director of Quality Innovation and Risk Management
As Director of Quality Innovation and Risk Management, Maghen focuses on proactive Quality-by-Design (QbD) and risk-based approaches to quality management. She has ownership of the MPBC SOP development/management lifecycle, the creation of role-based curriculum trainings, providing support for clinical program risk management activities, assisting in QAU systems deployment, supporting TMF inspection readiness activities, and assisting in facilitating inspections.
Prior to moving to Quality Assurance, Maghen spent 2 years at MPBC building critical work functions in support of data and systems management activities. As part of this enormous effort, Maghen helped to staff and manage the Clinical Systems and Document Control functions which resulted in an increase in the department size by 900%. She also led development and implementation of strategic SOPs and processes to support risk-based validation of computer systems and established of a QbD approach to TMF operational oversight by defining KPIs and oversight strategy. Maghen also contributed greatly to the development of the TMF Inspection Readiness Plan to support inspection readiness organizational goals.
Prior to joining MAPS PBC, Maghen came to us with a wealth of clinical research related skills from over 10 years of experience as a research coordinator, systems project manager/administrator and risk-based monitor from various positions within academia and industry.
In her spare time, Maghen enjoys spending time with her daughter and her golden retriever in their hometown of Kansas City, knitting bespoke wardrobe pieces, working out, traveling, organizing her closets, and collecting fantastic earrings!