Donna Gulbinski

Donna Gulbinski is currently the Chief Quality & Regulatory Affairs Officer at Civica, Inc., a new independent not-for-profit company founded by health care systems to address critical generic drug shortages caused by market failures. Donna was previously at Lachman Consultant Services, LLC where she was Vice President of the Compliance Practice. Prior to that Donna was the Head of Quality for Bristol-Myers Squibb where she led Quality through 13 NME approvals with flawless pre-approval inspections, built, qualified and approved several biologics facilities and led transformational activities in moving from 34 sites to 12 both from a quality perspective and as the CMC regulatory leader.
Donna’s expertise spans a strong foundation in technical and quality & compliance including basic research at Merck & Co., Inc. across cardiovascular, bone biology, HIV, anti-coagulants and multiple drug resistance.