Michele Smith, MS, CQA, has joined MilliporeSigma as Head of Global Quality Systems, based in Rockville, Maryland. The role expands Smith’s remit from a North America-focused quality systems function to one spanning MilliporeSigma’s global operations, and keeps her within the Maryland biopharma corridor where she has spent the bulk of her two-decade career.
About Michele Smith
Smith brings more than two decades of quality assurance and compliance leadership across the biopharmaceutical industry to the role. She joins MilliporeSigma from Miltenyi Biotec, where she spent nearly four years as Director of Quality Systems North America in Gaithersburg, Maryland. Before that, she was Associate Director of Quality Management at Lentigen Technology, a cell and gene therapy vector manufacturer, and Senior CAPA Manager QA at Lonza.
Earlier in her career, Smith served as Associate Director, Audit & Inspection at AstraZeneca, where she led GCP and clinical research compliance activities, quality assurance audits, and CAPA plan development in Gaithersburg. She spent nearly five years at MedImmune, rising from QAD Supervisor to QA Manager, and began her career as a QA Associate at Baxter BioScience in Beltsville, Maryland.
Smith holds a Master of Science in Chemistry from Howard University and a Bachelor of Arts in Chemistry from Lincoln University. She is a Certified Quality Auditor (CQA).
About MilliporeSigma
MilliporeSigma is the U.S. and Canada life science business of Merck KGaA, Darmstadt, Germany, serving researchers, biopharmaceutical manufacturers, and other organizations across the life sciences. The company offers a broad portfolio of products, technologies, and services supporting drug discovery and development, laboratory research, diagnostics, and pharmaceutical manufacturing.
Its portfolio includes laboratory chemicals and reagents, analytical and filtration technologies, lab water purification systems, molecular biology and protein research tools, and solutions for biopharmaceutical production. MilliporeSigma also provides contract development, manufacturing, and testing services through businesses and brands including Millipore, Sigma-Aldrich, SAFC, Supelco, Milli-Q, and BioReliance.
