Senior Manager with more than 25 years of extensive Project, Quality, Regulatory, and Validation background including: Provide Leadership for All Areas of Quality. Implement Validation/Protocol Requirements. Supplier Audit and Evaluation Management Write and Review SOPs for Entire Operation. Implement ISO 13485 and 820 QSR Specs. Reduce defects and Improve product flow. Develop and Review Entire SDLC Documents Compliance with ICH, EU and Japan guidelines Regulatory Compliance with FDA, & cGxP. Compliance with ITIL, NIST, and SOX Specs Statistical Sampling Plans and Analysis Direct a Large number of Personnel. Compliance with 21 CFR Part 11 Software testing w/ Quality Center Develop and lead GxP training.
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