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.
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.