Stephanie Gaulding

Ms. Gaulding serves as our Director of Regulatory Compliance, bringing 25 years of experience in quality management systems and validation program management in Pharma, Biotech, Medical Device, and related life science industries. Drawing on her extensive background, Ms. Gaulding develops and delivers efficient and sustainable quality management systems assuring compliance with global regulatory requirements and industry best practices. Over the past five years, her consulting services have helped both start-up and industry-leading clients successfully pass regulatory inspections. Ms. Gaulding has also held Quality Management leadership positions at Mediatech, Inc. and Boehringer Ingelheim Chemicals, Inc. Ms. Gaulding is an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional. She holds an M.Sc. in Biotechnology from Johns Hopkins and a B.Sc. in Biology from Virginia Tech. Ms. Gaulding is actively involved in PDA, ISPE, and ASQ through co-teaching ISPE’s “Applying Quality Risk Management” course, serving as a member leader in ASQ Human Development and Leadership Division, participating in the Certified Pharmaceutical GMP Professional Exam development process, and serving on the PDA member newsletter editorial committee. Her extensive GxP knowledge and experience with multiple regulatory authorities coupled with her passion for developing and working with people result in a proven track record of successful client collaborations to achieve their desired results.