Pharmaceutical quality professional with a background in preclinical and clinical oncology research and over ten years of FDA GxP-regulated quality assurance experience; advocates “Quality” as a built-in, shared value; encourages staff development and autonomy, authentic leadership and a culture built on quality, service, and relationships.Quality oversight of clinical cell therapy auto-graft transplant program, Animal Rule Ebola vaccine trials in BSL4 high containment, and clinical trial sterile drug substance/product manufacturing. Proficient at harmonizing and optimizing key quality processes (e.g., feasibility assessment, event investigations, risk mitigation) using data and value stream analytics. Demonstrated success in developing data management structures, tools, reports, and processes to identify, track, and evaluate critical performance metrics and continuous improvement projects.Established SMART Quality Solutions (smartqualitysolutions.com) consulting and pursuing Six Sigma Green Belt and data science continuing education to adopt and adapt emerging technologies (e.g., SMART), reinforce quality fundamentals, and optimize SMART quality assurance methodologies within the pharmaceutical industry.