Michelle Smiley
Director Site Quality and Solutions Transformation @Fresenius Medical Care
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WORK HISTORY
Director Site Quality and Solutions Transformation @Fresenius Medical Care
Knoxville, TN, US
EDUCATION
The University of Akron
Bachelor of Science (BS), Biology/Biological Sciences, General
SKILLS
ABOUT MICHELLE SMILEY
Experienced Quality Leader experienced in Pharmaceutical drug and Medical device manufacturing. Quality Control laboratory management with a demonstrated history of working in the pharmaceutical drug industry. Quality Assurance and Quality systems specialist dealing with 21CFR 210/211/820 and ISO 13485. Skilled in quality systems, manufacturing, FDA regulations /regulatory affairs, audit hosting, laboratories, chemistry, microbiology, data integrity, sterilization, and cGMP. Strong quality assurance professional with a Bachelor of Science (BS) focused in Biology/Biological Sciences. Proven regulatory history with FDA, CDER, CBER, CDRH, ANVISA, Health Canada, TGA, MHRA, and global Regulatory Agency. Experienced in CMO and proprietary processes ranging from clinical to marketed distributed product life cycles.
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