Head of Global Quality Management Systems
Dawn Lundin comes to MAPS PBC with over 25 years of quality assurance and compliance experience from the pharmaceutical industry, academia, and non-profit affiliations. After completing internships at SmithKline Beecham (now GSK) and a full-time position working at Xenobiotic Laboratories for a year, she began a 20-year career at Merck as an Associate Chemist in the Animal Formulation Design group, moved on to a Supervisor role in clinical packaging, then joined Worldwide Clinical QA traveling globally to conduct investigator, subsidiary, pharmacovigilance, and vendor audits for infectious disease, vaccine, cardiovascular, women’s health, and oncology studies. As a subject matter expert in quality across GxPs, Dawn supported regulatory inspections and conducted due diligence visits for many acquisitions and licensing agreements. Dawn developed the first Issues Escalation program, co-authored the first Quality Manual for the research division, and was invited to join Transcelerate to collaborate in the development of white papers, tools, and training for knowledge sharing of best practice in risk-based quality management. Dawn also volunteered for the National Veterans Legal Services Program (NVLSP) for Merck reviewing VA medical charts to create advocacy briefings for Veterans deserving combat related service compensation. In 2018, and in attempt to gain more exposure to the patient experience, Dawn chose to leave Merck and accepted a position heading the compliance unit for the Office of Clinical Research at the University of Pennsylvania managing the compliance program for the Perelman School of Medicine.
Dawn has a Master of Science in Quality Assurance and Regulatory Affairs from Temple University, a Bachelor of Science in Biology from Delaware Valley University, and a Certificate in Management Engagement from the Wharton School. Dawn holds additional certificates in Facilitative Leadership, Root Cause Analysis, Change Management, and a green belt in six sigma. She has retained her faculty affiliation with the University of Pennsylvania as the Director of the Quality Assurance course of study in the Master of Science Regulatory Affairs graduate program, is a member of the MRA Program Committee, and is also on the alumni board for Delaware Valley University.
In her spare time, Dawn enjoys time with family, watching her 17-year-old daughter outwit her husband, and snuggle time with her dog Phoebe and rescue cat Gizmo.