Biographies

Richard M. Siconolfi

Richard M. Siconolfi has been involved with toxicology, quality assurance, drug development, and regulated computerized systems since 1977. He received his Bachelor of Science degree in Biology from Bethany College (West Virginia), and his Masters of Science degree in Toxicology from the University of Cincinnati (including minors in Environmental Health and Computer Sciences). He was first hired by The Standard Oil Company in 1976 where he was a scientific advisor to the legal team involved with the Acrylonitrile hearings at the Food & Drug Administration. In 1978 he directed and managed the establishment of the Quality Assurance Section for The Gulf Oil Corporation's Life Sciences Laboratory. This included designing and implementing an audit plan to evaluate the validity of pesticide studies conducted by Industrial Bio-Test Laboratories. In 1985, he set up and managed the Toxicology, Regulatory Affairs and Quality Assurance Department for the Sherex Chemical Company (a subsidiary of Schering AG).

In 1988, Mr. Siconolfi accepted a position with the Procter & Gamble to manage the placement of toxicology and safety studies. This included conducting routine GLP compliance and system audits. At the same time he scheduled and conducted annual internal GLP audits for all Global Business Units. His next assignment at P&G required him in 1993 to setup, establish and manage the Clinical Quality Assurance Section for the Non Prescription Drug Division. In 2000 Mr. Siconolfi moved into information technology where he is currently Director for Computer.

Mr. Siconolfi is one of the co-founders the Quality Assurance Roundtable—the predecessor to the Society of Quality Assurance where he is a charter member. Mr. Siconolfi has held many elected and appointed offices, including the Office of President in 1990-1991. He founded the Society's Beyond Compliance Specialty Section and became its first president. He is a member of the Computer Validation Initiative Committee, Beyond Compliance Specialty Section, and the Regulatory Forum Council. He is also members of British Association of Research Quality Assurance (BARQA), Drug Information Association (DIA), and The Society for Life Science Professional (ISPE).