Janis Little is Vice President, Global R&D Quality at Allergan. In this role she is responsible for oversight of the R&D quality function, setting strategic direction for the organization and ensuring development and implementation of a risk-based audit program, inspection management, product development quality assurance, and medical device quality oversight. Janis currently leads TransCelerate’s Clinical QMS Workstream and was a co-author of the Clinical QMS conceptual framework.