Ms. Mc Guinness is the Principal and Founder of Pharmaceutical Compliance Partners, LLC (PCP), a boutique business consultancy focused on delivering value to its customers through management consulting, assessments, strategy and operations consulting within the Regulatory Affairs, Quality Assurance and Commercial Compliance disciplines of the pharmaceutical / biotech industry. She loves working with start-up companies, especially those passionate about rare diseases, neuroscience or unmet medical needs.
Prior to founding PPC, Ms. Mc Guinness was the Senior Director of Compliance Operations at AstraZeneca where she was a member of Diabetes and Cardiovascular Therapeutic Area’s leadership team and provided strategic compliance advice on commercial activities. She was also a member of the Compliance leadership team and provided direction to the Compliance & Ethics Leaders team. Prior to joining AZ, Ms. Mc Guinness held positions at Janssen, Veloxis Pharmaceuticals, Mylan, PA Consulting, Octagon Research Solutions (now part of Accenture), Sanofi, Liquent (now part of Parexel) and Ranbaxy Pharmaceuticals Inc. Ms. Mc Guinness has participated in several joint industry-agency initiatives. She was awarded the FDA Commissioner’s Special Citation for her contribution the HL7 Structured Product Labeling standard & FDA guidance.
Ms. Mc Guinness earned an MSc in Quality Assurance/Regulatory Affairs from the Temple University School of Pharmacy and is currently a Regulatory Science doctoral student at the University of Southern California. She earned a BA in Biology-Biotechnology from Kean University and held RAC certification from 2001 – 2014.
Ms. Mc Guinness is passionate about rare diseases and unmet medical needs. She volunteers as a scientific advisor for CureCADASIL (the CADASIL Association) and for several animal rescues. In her free time, Ms. Mc Guinness trains with West Chester Women’s Multisport and competes in multisport events. She unexpectedly qualified to represent TeamUSA in 2019/2020 and is training to compete in aquathlon at the 2021 International Triathlon Union World Championships in Almere, Netherlands.
More details can be found LinkedIn: https://www.linkedin.com/in/michelle-mcguinness-pharma/