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Ann Kolesar, MBA
Senior Director of Quality & Compliance
Ann Kolesar, MBA, is a seasoned Quality professional, with nearly 30 years experience in FDA regulated industries. She brings extensive knowledge of manufacturing and aseptic processing in pharmaceutical, medical device, biologic, and tissue bank environments, and her diverse background includes expertise in Quality Operations and International Regulatory Compliance (US, EU, CAN).
After beginning her career in the production of aseptic pharmaceuticals, Ann has held numerous leadership positions to include oversight of Quality Assurance, Quality Control, Quality Engineering, Quality Compliance, and Regulatory Affairs. Experience includes direct oversight of Manufacturing and/or Quality (US and OUS) for a variety of dosage forms to include human parenteral, oral solid, and topical pharmaceuticals, Class III medical devices including combination products, HCT/Ps and veterinary products, in traditional manufacturing, contract manufacturing and virtual environments. Development and management of Quality Systems includes 21 CFR parts 210, 211, 820, 600, 11, 1271; EU MDD 93/42/EEC (2007/47/EC); Ca. C.R.C, c. 870 and SOR/2003-196; AATB; and ISO 13485, 14971 and 9001. Regulatory and Grant submissions include DMF, (Ca) PLA and CTA, IND, ISO 13485 and SBIR.
A proven, cross-functional leader, Ann has consistently met the challenges facing corporate, small business, and start-up companies, utilizing creative approaches and risk-based strategies to achieve compliance objectives while actively managing budget impact. Currently, she serves as the Sr. Director Quality & Compliance for Equus Innovations (Phoenix, Arizona), the manufacturer of the RenoVō® equine allograft.