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Melissa McAfee

Exec. Director Global Cell Therapy Quality Systems and Compliance

Bristol Myers Squibb•Bothell, Washington, United States

View LinkedIn Profile
Experience36+ Years
LevelCXO

Executive Overview

I am a professional with over 25 years of experience within the biotech industry. My experience within Quality and Manufacturing has provided me with a unique perspective that has allowed me to be recognized as a top performer in both Quality and Manufacturing throughout my career. I have worked in both management and individual contributor roles in the pharmaceutical industry that demonstrates my abilities as a results oriented, self-motivated individual that is able to work well with all levels within an organization. I have extensive knowledge and experience with Quality systems and business processes. I also have experience in delivering complex multi-disciplinary projects within a highly regulated environment, which has helped me become adept in identifying and deploying continuous improvement projects and initiatives that ensure compliant, stable, high quality, and cost-effective processes. As an ambitious and capable individual, I have gained expertise in many areas of the pharmaceutical industry including Quality Control, Supply Chain, Quality Assurance and Manufacturing.

Career Timeline

Professional employment history
  • Aug 2021–Present· 5 yrs 3 mos
    • Executive Director, Global Cell Therapy, Quality Systems and ComplianceCurrent
      2026–Present
    • Senior Director Quality Systems and Compliance
      Aug 2023–2026
    • Director Quality Systems
      Aug 2021–Sep 2023
  • Sep 2020–Aug 2021· 11 mos
    • Director, Quality Assurance Operations
      Sep 2020–Aug 2021
  • Aug 2018–Sep 2020· 2 yrs 1 mo
    • Director, Quality Systems and Compliance
      Aug 2018–Sep 2020
  • Nov 2017–Aug 2018· 9 mos
    • Director, Quality
      Nov 2017–Aug 2018
  • 2016–Oct 2017· 1 yr 9 mos
    • Associate Director, Quality, IT Systems
      2016–Oct 2017
  • Jun 1997–Dec 2015· 18 yrs 6 mos
    • Senior Manager Quality Systems
      Aug 2012–Dec 2015
    • Sr Manager Production Scheduling
      Jun 2011–Aug 2012
    • Sr. Specialist Manufacturing - Quality Systems /Capacity Planning
      Mar 2009–Jun 2011
    • Sr. Specialist Manufacturing
      Aug 2006–Jun 2011
    • Specialist, Manufacturing
      Apr 2004–Aug 2006
    • Manager, Quality Assurance
      Dec 2002–Apr 2004
    • Quality Assurance Associate/Specialist
      Sep 1998–Dec 2002
    • Coordinator, Training
      Jun 1997–Sep 1998
  • Sep 1995–Apr 1997· 1 yr 7 mos
    • Mfg Technician/Quality Product Release Coordinator
      Sep 1995–Apr 1997
  • Feb 1995–Sep 1995· 7 mos
    • Technician, Laboratory
      Feb 1995–Sep 1995
  • 1990–1992· 2 yrs
    • Production/Fabrication Technician
      1990–1992

Education

BS

Microbiology

Colorado State University

Executive Relationship Map

Reports To
Melissa McAfee
Vice Chair & President
Chief Financial Officer
Chief Technology Officer
Chief Operating Officer

Executive Network Preview

BizKonnect has mapped this leadership network including reporting hierarchies, peer connections, and cross-functional relationships.

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Skills & Expertise

20 of 20 skills
GxPComputer System ValidationTechnology TransferManagementMicrobiologyQuality ControlQuality SystemCAPATrackWiseGMPFDAValidationCleaning ValidationQuality AssuranceProcess ImprovementLIMSPharmaceutical IndustryBiotechnologyQuality AuditingGLP