Ylva Ek is Chief Quality Officer (CQO) at KeyPlants AB in Stockholm, Sweden. In her role, she is responsible for the Company Quality System and Strategy as well as Environment, Health and Safety (EHS) and Sustainability. She has extensive experience in building, outfitting and qualifying GMP manufacturing facilities from companies in the pharma and biotech industry. Her 20+ years’ experience also includes 7 years spent at the Swedish Medical Products Agency (Läkemedelsverket), a part of the European medicines regulatory network. There she was nominated as a National Expert for Sweden to EMA. Ylva has held Global responsibilities in many of her roles and has experience working in Europe, Middle East and Africa (EMEA), China, Latin America and the United States.
Ylva currently serves as a Director on the ISPE International Board of Directors and is Past Chair of ISPE Nordic Affiliate (representing Sweden, Denmark, Finland, Norway, and Iceland). She serves on the ISPE European Leadership Team, is Co-Chair of the ISPE Global Regulatory Quality Harmonization Committee (RQHC) and is a member of the Steering Committee of the Europe-Middle East-Africa Regional Focus Group (RQHC EMEA RFG). She is also Board Liaison to the Drug Shortages Initiative and a member of the Regulatory sub-group in the ISPE Biotechnology Special Interest Group (SIG). She has served as Chair and Track Lead in several ISPE Europe Conferences and currently serves on the Planning Committees of the 2021 ISPE Biotechnology Conference and Workshop and the 2022 ISPE Europe Annual Conference. She received her Master of Science in Biology (minor in Pharmacology) at Uppsala University and has been a guest researcher at the University of California San Diego (UCSD) and Salk Institute in La Jolla, CA.