Karen H.

Karen H. has a diverse work experience in the pharmaceutical industry. Karen is currently serving as the Head of External QA at Allogene Therapeutics since January 2022. Prior to this, they worked at Apellis Pharmaceuticals as the Director of Global Quality Assurance from February 2021 to December 2021, and as the Associate Director of Global Quality Assurance from March 2019 to February 2021.

Karen also has experience working at Genentech, where they served as the Principal Quality Site Manager for External Quality from March 2017 to March 2019 and as the Senior Quality Site Manager from April 2013 to March 2017. In these roles, they provided quality and compliance oversight for commercial products manufactured at contract manufacturing organizations (CMOs) and ensured compliance to regulations and quality agreements.

Before joining Genentech, Karen worked at Dynavax Technologies as a Manager of Quality Assurance (Commercial) from August 2012 to April 2013. Karen also held various positions at Amgen, including Manager of International Quality (Asia) from 2010 to 2012, where they provided oversight on international partnered companies and supported product commercialization and launch, and Sr. Validation Engineer from 2005 to 2010.

Karen's earlier experience includes roles at Bayer, where they worked as a Validation Specialist from 2004 to 2005, and as a Quality Engineering Specialist from January 2002 to August 2004.

Overall, Karen has extensive experience in QA and regulatory compliance within the pharmaceutical industry, with a focus on external quality, CMO oversight, and international partnerships.

Karen H. holds a Bachelor of Science (B.S.) degree in Chemical Engineering from the University of California, Berkeley. Karen has also obtained a Quality Certification Program from Roche Genentech in October 2016. Additionally, Karen H. holds a certification as a Certified Quality Engineer from the ASQ, but the month and year of obtaining this certification are not provided.