Sarah Pope Miksinski has been with AstraZeneca since February 2018 and is currently an Executive Director in CMC Regulatory Affairs. Her duties include leadership of a global team covering end to end CMC regulatory strategies, as well as serving as a key contributor to several ongoing initiatives including continuous manufacturing, ICH M4Q, benefit risk and Q12 implementation. She represents AstraZeneca in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s Regulatory Steering Council, and supporting multiple other advocacy efforts. She was appointed to the EWG (PhRMA Topic Lead) for ICH M4Q in 2020, and is the Rapporteur of the ICH Quality Discussion Group.