Nicole Quinlan Email Address

Director, Technical Management Medical Imaging

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

Over 20 years of experience working in the Life Sciences industry with extensive management experience in the delivery and quality assurance of life sciences informatics solutions. Areas of expertise include: • Building and adapting regulatory and industry compliant Quality Management System (QMS) development and business process analysis and redesign. • Complex client and team line management, professional development, and change management • Implementing regulated software projects using multiple SDLC methodologies, including Agile, from project definition through retirement: o Gather and document system requirements through interviews, workshops and observations using current and past experiences o Process and procedure diagramming and documentation o Develop application design specifications, and traceability matrixes o Support system in conjunction with third party vendors as systems is deployed o Assist in Validation activities as system is developed o Deployment planning, organizational change management, and end user curriculum development and delivery o Continue to support system, construct and execute change controls and maintain system health and compliance • Tool design and implementation for Audit Management, Root Cause Analysis, CAPA, Project and Program Management, Collaboration, Risk, Change, Quality, Requirements, and Test Management (e.g. TrackWise, HEAT, SharePoint, MS Project, TestTrack) • SharePoint team collaboration and content management site planning, workflow development, deployment and administration • Regulatory standards compliance, audit conduct and facilitation (ISO 9001:2000, GxP, FDA 21 CFR Part 11, Annex 11, Health Canada, GMP Guidelines, GAMP4, GAMP5, SOX, Sunshine Act)