Joyce M. Hansen

Johnson & Johnson
Vice President, Sterility Assurance
Joyce Hansen joined Johnson & Johnson as Vice President of J&J Sterility Assurance in 2012. Joyce is responsible for providing strategic vision, leadership and governance for sterility assurance E2E lifecycle management for sterile products (aseptically produced or terminally sterilized), and the microbial control for non-sterile products across Johnson & Johnson. Additionally, Joyce is responsible for Johnson & Johnson’s representation in U.S. and international sterile and aseptic standards settings and internal sterile process knowledge management activities including learning, standards, competencies, and best practices to Johnson & Johnson companies worldwide. Joyce is a member of the Johnson & Johnson Quality & Compliance Leadership Team.

Joyce is a recognized industry leader in sterility assurance and sterilization practices, and she has over 38 years’ experience in sterility assurance. Prior to joining Johnson & Johnson, Joyce was the President and founder of J.M. Hansen & Associates, Inc., a consulting firm that provided manufacturing companies with strategic plans for sterility assurance, guidance on the use/applications for internal sterilization equipment or the use of contract sterilization and laboratory services. She is specialized in microbiological methods, terminal sterilization (e.g., radiation by gamma, electron beam and X-ray; ethylene oxide; moist and dry heat) and aseptic processing. Prior to consulting, Joyce spent six years working for Baxter Healthcare Corporation as Vice President, Sterility Assurance and Sterilization Core Technical Competency Champion. Joyce also held sterility assurance positions in R&D and/or operations management for Sherwood Davis & Geck, Isomedix, and Becton Dickinson & Company.

Joyce holds a B.S. in Microbiology from South Dakota State University, and a Masters in Management from the Kellogg Executive Management Program at Northwestern University. Joyce has authored/co-authored numerous articles in technical journals and/or chapters in books on sterilization, and is involved in several industry activities responsible for developing industry standards for sterility assurance. She previously served as Convenor of the ISO Working Group on Radiation Sterilization and as co-chair of the Association for the Advancement of Medical Instrumentation (AAMI) working groups to develop standards on Radiation Sterilization, Sterility Assurance Levels, and Microbiological Methods.