Manager, Clinical QA

  • Manage GCP QA activities in support of NBI development projects and commercial product clinical trials.
  • Develop effective GCP QA SOP’s and associated training
  • Develop internal/ external audit strategy and conduct of clinical site GCP inspections
  • Manage external consultant auditors
  • Develop and managing internal and external GCP training programs
  • Train and preparing clinical sites for FDA inspection
  • Be internal GCP QA subject matter expert
  • Work with other GXP functional areas (GLP and GMP) as needed.
  • Develop NBI Quality Systems and participating in and supporting QA activities for commercialization.

Requirements:

The candidate must have broad experience GCP and QA including quality systems.  Position would be suitable for someone who has spent time as a clinical research associate prior to entering the QA function.  Travel required.  Education: Bachelor’s degree or equivalent experience in a clinical GCP and / or QA function with 10+ years in the pharmaceutical industry.

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