Stephanie Gaulding

Biography

Stephanie has over 20 years of experience in quality systems and validation program management in FDA and EU regulated companies and over 3 years providing quality and regulatory consulting services. She has held site Quality Management positions with responsibility for development, redesign, streamlining and implementation of quality systems and validation programs to comply with global regulatory requirements and industry best practices for drugs, biologics and medical devices. As a proven leader Stephanie has ability to identify root causes and quickly resolve issues, and implement efficient business processes to support ongoing compliance. She has also been responsible for the remediation of quality systems at several pharmaceutical and medical device manufacturing sites. She is an ASQ Certified Quality Auditor and Certified Pharmaceutical GMP Professional experienced in auditing contract manufacturers, raw material suppliers, equipment suppliers, computer system vendors and component suppliers. Stephanie also has solid understanding of drug, biologic and medical device product development, manufacturing, handling and control processes. In addition, she has developed and validated Quality Control in-process and release methods including analytical chemistry and microbiological/biological procedures.

Research Interest

Engineering