Alison Mc Donald
About Alison Mc Donald
Alison Mc Donald is the Manager of Quality Systems - Deviation Management at Bristol Myers Squibb in Bothell, Washington, with a background in quality assurance and fermentation process engineering.
Title at Bristol Myers Squibb
Alison Mc Donald holds the position of Manager, Quality Systems - Deviation Management at Bristol Myers Squibb, located in Bothell, Washington, United States. In this role, she oversees the Deviation Trending Program, ensuring a systematic and process-based analysis of recurring deviations.
Past Roles at Grifols Diagnostic Solutions Inc.
Alison Mc Donald previously worked at Grifols Diagnostic Solutions Inc. from 2016 to 2018. She served as QA Specialist II in Fermentation & Upstream Manufacturing in Emeryville, California, overseeing quality assurance for fermentation processes.
Former Role at Genentech
Prior to her tenure at Grifols Diagnostic Solutions Inc., Alison Mc Donald was a QA Specialist in Investigational Medicinal Products Quality Engineering and Validation at Genentech. She worked at the South San Francisco, CA location from 2014 to 2016, focusing on quality engineering and validation for medicinal products.
Educational Background
Alison Mc Donald acquired a Master of Science (MS) in Individualized Genomics and Health from The Johns Hopkins University, where she studied from 2018 to 2021. She also holds a Bachelor of Science (BS) in Biomedical/Medical Engineering from the University of Southern California, completed from 2008 to 2012.
Project Involvement and Contributions
Alison Mc Donald played a key role in supporting the approval of Bristol Myers Squibb's Breyanzi, the fourth CAR-T product approved by the FDA. She also designed the Investigator Qualification Program and created the Event Response Program at Bristol Myers Squibb.
Interest and Mentorship in Biopharmaceutical Industry
Alison Mc Donald is passionate about developing novel therapeutics for patients with unmet medical needs, particularly in precision medicine and autologous therapy. She mentors cross-functional groups on deviation management and provides front-room support during audits and inspections.