Susan Schniepp

RCA Distinguished Fellow

Susan Schniepp is a Distinguished Fellow and Knowledge Leader for Regulatory Compliance Associates® (RCA), where she provides training, guidance, and strategic insight to RCA professionals and clients on evolving regulatory and quality challenges across the pharmaceutical, biotechnology, and medical device industries. With more than 40 years of experience in quality assurance and regulatory compliance, Susan has extensive expertise in cGMPs, inspection readiness, change control, investigations, supplier quality, batch record review, compendial affairs, and quality systems.

Throughout her career, Susan has held quality leadership positions with Allergy Laboratories, Inc., Oso BioPharmaceuticals LLC, Searle, Abbott, and Hospira, with responsibilities spanning quality assurance, quality control, regulatory affairs, laboratory analysis, method validation, complaints, labeling, investigations, and other quality systems.

Susan has been deeply involved with the Parenteral Drug Association (PDA) for more than two decades and has served in numerous leadership and volunteer roles. She served on the PDA Board of Directors from 2011 to 2013 and again from 2016 through 2019, and subsequently served as Chair-Elect, Chair, and Immediate Past Chair of the PDA Board. She completed her Board service at the end of 2025. Susan has also served on numerous PDA committees and planning groups, including the PDA/FDA Joint Regulatory Conference Planning Committee, where she has been involved since 2002. Her PDA contributions have included work related to regulatory affairs, quality, manufacturing data integrity, and purchasing controls.

Susan is a recipient of several prestigious PDA honors, including the Distinguished Author Award, Distinguished Service Award, and Gordon R. Personeus Award. Her publications include Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, which earned the 2007 PDA Distinguished Author Award. She has also co-edited and contributed to Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers.

A recognized industry author and thought leader, Susan has served as a columnist and member of the editorial advisory board for Pharmaceutical Technology since 2007 and has also contributed to BioPharm International. She previously chaired a USP Monograph Development Expert Committee from 2005 to 2010 and has presented extensively at PDA conferences and other industry forums.

Susan continues to contribute to the life sciences industry through articles, podcasts, videocasts, presentations, webinars, and industry working groups. Her combination of practical quality experience, regulatory knowledge, and extensive involvement in industry standards and professional organizations provides clients with a broad perspective on quality and compliance challenges.