Elena L. Mack, BSc, MSc, CQA (ASQ). CMQ/OE (ASQ), CPGP (ASQ)
Elena Mack is the Vice President, Quality – Contract Manufacturing and Medical Device at West Pharmaceutical Services in Exton, Pennsylvania. Previous to this role, she was VP, Quality Innovation & Systems at West. Elena has held various quality management roles in Quality in the combination products, contract manufacturing, pharmaceutical and medical device space in the span of 20 years. She began her career in the pharmaceutical industry as a Microbiologist for Wyeth Ayerst Pharmaceuticals.
Elena received her Bachelor’s of Science degree in Microbiology from the University of the Sciences in Philadelphia and her Master’s of Science degree in Quality Assurance & Regulatory Affairs from Temple University. She is a Senior Member of the American Society for Quality (ASQ) and holds current certifications for Certified Quality Auditor (CQA), Certified Manager of Quality/Operational Excellence (CMQ/OE) and Certified Pharmaceutical GMP Professional (CPGP). She served on the Board of Directors for ASQ’s Food, Drug & Cosmetic Division from 2008-2017.
She has presented and written articles previously on numerous quality topics such as Change Control, Laboratory Compliance, Inspection Readiness, Lean Six Sigma for QA/QC, Data Integrity, Auditing and cGMPs for Dietary Supplements.