Kip Wolf is a bioscience management consultant and an infosec expert who lives in south Florida and works with life sciences clients and partners both on the east coast of the United States and globally to improve human health and shareholder value.
He started working in the life sciences industry while president and CEO of GxP Data Services, a company he founded in 1997.
With his current consulting practice (Thaumazo Bioscience Management, Inc.), he provides management consulting, advisory services, and outsourced leadership to life science companies during periods of transformational change. Most recently he was a technology executive at X-Vax Technology, a pre-revenue pre-clinical virtual biotech company committed to developing vaccines against pathogens acquired by mucosal infection such as herpes.
Since 2020, he has actively volunteered as an advisor, mentor, and instructor for MedTechVets to bridge the gap for fellow military veterans by providing personalized career transition services, mentorship, and career development guidance. MedTechVets is a 501(c)(3) nonprofit serving military veterans during career transition and beyond, by building a professional bridge to finding and keeping meaningful employment in the Medical Technology Industry through meaningful and lasting professional relationships.
Since 2017, he is actively leading and contributing to initiatives co-sponsored by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) as the Healthcare Products Collaborative (HCP, see https://www.healthcareproducts.org/), including the AFDO/RAPS AI Collaborative Community with CDRH Participation and the AFDO/RAPS HPC AI Initiatives (both the AI Summit and the AI Working Teams). As a sub-team co-leader of the AI in Operations working team (https://www.healthcareproducts.org/ai/working-teams/aio/) he has directly contributed to the advancement of the increase in predictive assurance of product quality across life science business operations (e.g., manufacturing, quality, supply chain, etc.) through the power of artificial intelligence (AI) and machine learning (ML). He has been a thought leader on data integrity and information science in the life sciences industry since the late 1990’s. He has also recently co-led and co-authored the development of a data integrity standard that is written as industry agnostic and is published by the American Society for Quality (ASQ) as "ASQ TR3:2022 Data Integrity: Guidelines for collecting, recording and retaining data within the scope of quality management systems" with the potential to be applied as an ANSI Standard.
He has completed formal graduate studies in Drug Development at Temple University and holds an undergraduate degree in Management of Information Systems and an MBA from Eastern University.
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