Michele H. Piepoli Johnson & Johnson

Recognized as an expert in Quality and Compliance, Michele has over 45 years’ technical experience in the pharmaceutical industry, including 35 years in management. Michele has led domestic and international projects ensuring completion of regulatory commitments. With deep technical knowledge and experience in the global pharmaceutical industry including Quality, Compliance and Regulatory, areas of expertise include Quality Systems, Laboratory Operations and Excellence, Inspection Readiness, Process Improvement, management of Health Authority inspections, as well as responsible for Inspection Readiness programs, and major contributor to HA response activities. A facilitator of change and learning, Michele has demonstrated the knowledge, passion, and ability to develop and conduct effective training workshops. Core experience includes conducting facility audits and playing a key role in the development, implementation and oversight of Quality Systems, and completion of large-scale, consent-decree-driven projects ensuring compliance to Health Authority commitments. Long term assignments have included: VP Quality (QA/QC); Site QA Head and Site Compliance Head at a major major Vaccine international company, CDMO and Biotech international company. Michele was responsible for the regulatory and quality oversight of all operations performed within two international regional sites.