Magaly E. Aham Takeda

Magaly currently works at Takeda as a Senior Director Quality Compliance for the Global Oncology & Biologics Division. Prior to joining Takeda she worked in consulting for Pharma-BioServ US Inc., MedImmune, Pfizer, Wyeth and Schering Plough in positions of increased responsibility. She holds a Bachelors Degree in Chemistry from the University of Puerto Rico and a Master Degree in Bioscience and Regulatory Affairs from the Johns Hopkins University in Maryland, US. She has comprehensive management experience in Quality Assurance, Quality Systems, Compliance, Quality Control, Validation and Manufacturing Operations. Magaly has participated as a lead in companies undergoing remediation efforts such as Consent Decrees and Warning letter environments in which she has developed expertise in quality systems design and implementation and Risk Management. She is Kepner-Tregoe Problem Solving Decision Making(PSDM) Certified Trainer, former ASQ Quality Auditor (CQA), US-RAC, and a PR Licensed Chemist. She was the PDA QRM IG Coordinator for the past couple of years and recently was appointed Co-Lead of this QRM IG.