Carol Weiss

Senior Director, Quality Assurance at Wugen

Carol Weiss has over 20 years of industry experience in Quality Assurance. She joined Wugen in 2021 and has been instrumental in building the Wugen Quality systems, processes and team required to release GMP Drug Products for the Clinic. Prior to Wugen, Carol held broad range of Quality Assurance positions of increasing responsibilies at Pfizer, Wyeth BioPharma and Genetics Institute whichincluded a wide range of modalities and regulatory strategies and spanned the entire lifecycle of GMP drug manufacturing from Phase 1-3, BLA licensing and commercial. She is a Quality Subject Matter Expert in deviations, investigations, Root Cause Analysis, Quality Risk Management, and cGMP compliance, including documentation, vendor qualification and oversight, conducting and hosting audits and managing regulatory inspections.

Carol received her BS in Microbiology from the University of Southern Mississippi.

Timeline

  • Senior Director, Quality Assurance

    Current role

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