Nicole Hartley Ms

Nicole Hartley MS, CQA has extensive experience in quality systems within the biopharmaceutical industry, currently serving as Associate Director of Quality Systems at Dyne Therapeutics since November 2022. Prior roles include Senior Manager of Quality Systems and Quality Systems Lead at Rubius Therapeutics, and QA Manager at Keryx Biopharmaceuticals. Nicole has also held positions at Akebia Therapeutics and Alexion Pharmaceuticals, where responsibilities included managing change control processes, CAPA, deviations, and regulatory interactions. Nicole's earlier career involved significant roles at North Safety Products and Dow Chemical, focusing on laboratory testing and compliance audits. Educational qualifications include a Master of Science in Biotechnology/Regulatory from The Johns Hopkins University and a dual Bachelor's degree in Biology/Chemistry and Teacher Secondary Education Biology/General Science from Rhode Island College.