Rachel Kula

Principal Quality Consultant@Total Quality Excellence (TQE)
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Summary

QMS/eQMS Implementation and Optimization | GMP/GxP Compliance and Inspection Readiness | FDA, EMA, ISO Regulatory Expertise | Quality Culture and Leadership | Total Quality Excellence. A proven leader with a proven track record.I am a transformational expert in…

Work experience

  • Principal Quality Consultant

    Total Quality Excellence (TQE)
    2025.09-Current(a year)
  • Director Global Quality Compliance

    Moderna
    2022.04-2025.08(3 years)
  • Head Of Quality

    SGS Quay Pharma
    2022.01-2025.08(4 years)
  • Director of Quality Compliance

    Rentschler Biopharma SE
    2020.04-2022.01(2 years)
  • Associate Director Quality Compliance

    Lantheus Medical Imaging
    2018.11-2020.04(a year)
  • Director of Quality and Regulatory

    Mitralign Inc.
    2017.11-2018.11(a year)
  • Quality Assurance Manager

    Nova Biomedical
    2015.11-2017.11(2 years)
  • Senior Quality Operations

    Biogen
    2003.12-2015.11(12 years)

Educational experience

  • Boston University

    Master's Degree, Health Communication
    2013.01-2015.01(2 years)
  • Boston University

    Master's Degree Health Communication
    2003.01-2008.01(5 years)
  • Boston University

    Bachelor's Degree, Biomedical Laboratory and Clinical Sciences, Cum Laude
    2003.01-2008.01(5 years)
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