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.