Kathleen May, Founder and Owner of Triskele Quality Solutions, has more than 20 years’ experience as a Quality professional in the pharmaceutical, medical device and cannabis industries. She has worked in every aspect of quality management systems and is a sought-after consultant in regulatory and scientific standards. In her lead role at Triskele, Kathleen offers consultation services for GMP implementation, Standard Operating Procedure (SOP) development, audit readiness, validation, and training to testing laboratories, cultivation facilities, and manufacturing facilities.
Kathleen has worked at Fortune 500 companies such as Abbott Laboratories, Baxter Healthcare, Cardinal Health, Merz North America, Hospira, and Pfizer. While at Merz, she was instrumental in achieving the successful build-out of a microbiological infrastructure which allowed for in-house testing of bioburden and endotoxin. This project was completed in five months with an annual cost savings of $500,000 and a fourteen-day reduction in cycle-time of product-release to market.
Kathleen earned a B.A. in Biology with a minor in Chemistry from Carthage College in Kenosha, WI. She has held multiple management roles and earned a certification as a Certified Quality Auditor (CQA) from the American Society for Quality.
Kathleen is an executive member of the ASTM International Cannabis Standards Committee, D37. D37 is focused on creating quality and safety standards and guidance materials for cannabis products and processes. The committee is focused on the development of standards in seven technical areas:
- Indoor and outdoor horticulture and agriculture
- Quality Management Systems (QMS)
- Processing and Handling
- Security and Transportation
- Personnel training, assessment, and credentialing
- Industrial Hemp