William Miele PhD

Bill Miele is Director / Team Leader of the Microbiology and Aseptic Support group where he is responsible for the direction and development of internal quality and microbiological policies pertaining to the Pfizer aseptic manufacturing network and global functions. He also develops subject matter experts, site support liaisons and risk based site assessments of aseptic global manufacturing. Joining Pfizer in September 2004, he brought over 17 years of experience to Pfizer having expertise in corporate and site QA, quality systems auditing and assessment, and QC laboratory management in aseptic processing settings in the branded, generic, and contract arenas. Prior to his pharmaceutical career.

Dr. Miele spent a number of years in academia as Associate Professor of Biology, further developing and sharing his interests in his scientific specialization. He holds B.A. and M.S. degrees in biology and a Ph.D. degree with a concentration in microbial physiology from Virginia Tech. He is an active member of PDA, a contributing author of PDA Technical Report 35 microbiological training and TR 44 on risk based approaches in aseptic processing, a PQRI Working Group member for Post Approval Chances for Sterile Products, and he is member and Certified Quality Auditor of the American Society for Quality.