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Kevin Jenkins

Kevin M Jenkins

President, Quality Excellence Consultants & Former Vice President Quality Sterile Injectables, Pfizer

  • Retired as Vice President Quality Sterile Injectables at Pfizer in 2019 where he held positions of increasing responsibility.
  • Over 36 years of expertise in Quality, Operational Excellence, Technical Services and Operations.
  • Held senior quality operational leadership positions at Pfizer : Vice President – Global Quality Operations Established Products; Vice President – Global Aseptic Quality; and Vice President – Quality Excellence in India.
  • Vice President – Quality for 11 Pfizer sterile injectables sites world-wide. Sites located in Italy, US (Missouri, McPherson, Rocky Mount and Meridian St. Louis), India, Australia, China.
  • Leader for Corporate Microbiology and Aseptic Visual Inspection Group at Pfizer.
  • Four key Directors/VP reported to his role with responsibilities for Quality, Aseptic and Regulatory Compliance.
  • Sponsor/Leader Aseptic Quality Forum to assure quality, best practices and continuous improvement at aseptic sites.
  • Responsible for remediation of aseptic sites with compliance issues (US and India) such that regulatory status acceptable and no significant supply or regulatory issues.
  • Successful USFDA, EMA, ANVISA inspections.
  • Responsible for preparing the IV bag facility for the first FDA Pre-Approval Inspection for Zyvox at Halden, Norway in 1998.

     

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