Jennifer Kay is a QA professional with over 25 years experience in GMP biopharma, specializing in quality system implementation, management, and execution for clinical phase companies. Previously, JK worked at Seattle Genetics, Inc. as a Sr. Manager, starting as the company’s first QA employee and developing quality systems through commercialization of the company’s flagship product, ADCETRIS (antibody drug conjugate). She was instrumental in developing their QSMR (quality system management review) process, initiated the company’s quality culture program, and collaborated with PDA as a pilot participant to test the PDA quality culture assessment tool at the site. Prior to joining MRBC, Jennifer was the Quality Director at Neoleukin Therapeutics (de novo protein design), executing QA responsibilities for clinical manufacturing, and has most recently been consulting for a cellular therapy start-up company to implement phase-appropriate GMP systems. Early experience in GMP biopharma include manufacturing operator roles at Immunex Corporation (recombinant proteins) and Targeted Genetics Corporation (gene therapy). Jennifer holds a BSc in both Biology and Chemistry (biotechnology / biochemistry) from Eastern Washington University (EWU).