Accomplished QA/Validation Manager with extensive experience in the sterile injectable , transdermal, topical pharmaceuticals and biotechnology environments. Seasoned professional in managing cross-functional teams in technology transfer, scale-up and commercialization of new products and maintaining equipment, process and product validation life cycles. Skilled at orchestrating the project team in the transfer of technology from development to commercial product launch and through life-cycle management. Strong ability to "see the big picture" led to successful product submission to the FDA according to schedule. Facilitated regulatory requirements to market existing US product in the EU...
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