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Senior Director, Microbiology Regulatory Compliance
Johnson & Johnson
For the last seven years, Dr. Guilfoyle has been happily employed as the Senior Director, Microbiology & Analytical Regulatory Compliance with Johnson & Johnson, Corporate Compliance and Quality Control. He is responsible to provide scientific and compliance expertise to the corporate GXP audit teams, compliance remediation, and regulatory Intelligence and outreach functions. Dr. Guilfoyle serves as the expert on matters related to laboratory test standards, compendia requirements, cGMP and rapid microbiological methods. Collaterally he helps foster meaningful, credible and strong partnerships with health authorities ensuring that J&J is at the frontline in developing appropriate global microbiological laboratory requirements. Prior to working in industry, he had worked for over 40 years with the U.S. Food & Drug Administration (FDA) and was classified as an international expert in the field of pharmaceutical microbiology. He is currently serving his 21th year as a member of the USP expert Microbiology committee and is a member of the PDA Science Advisory Board. Dr. Guilfoyle has been an Associate Professor for two graduate courses entitled “cGMP” and “Process Validation”. He would someday like to retire and fish from his dock at his dream lake house.
Tuesday, September 28, 2021
08:30 – 08:49 EDT
Tuesday, September 28, 2021
08:49 – 09:30 EDT