Mary Oates, PhD
Mary Oates has 30 years of experience in the pharmaceutical industry in Operations, Quality, and R&D. She is currently Vice President, Compliance Services at Lachman Consultant Services, Inc. Prior to this, Mary spent 25 years at Pfizer, holding multiple leadership roles. In Operations, she was responsible for the Biotechnology and Consumer manufacturing plants and operational excellence for the entire manufacturing division. Mary was also the Global Quality Operations leader at Pfizer for eight years, with responsibility for quality oversight of all GMP activities.
Mary is currently a member of the PDA Board of Directors, where she sits on the PDA Foundation Committee, serves as Board Liaison to the Manufacturing Science and Operations Program, and is a member of both the Covid-19 Task Force and the Remote Audits/Inspections Team. Mary has been a key contributor to an ongoing series of PDA webinars on the topics of remote regulatory inspections and assessments.
She was also a member of the ICH expert working group for Q12, a Quality Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, and she has participated in numerous Pharmaceutical Research and Manufacturers of America (PhRMA) activities throughout her career.
Mary holds an undergraduate degree in Biochemistry from Queens College and a PhD in Analytical Chemistry from the University of North Carolina in Chapel Hill.