Increase the efficiency of good quality, reduce the cost of poor quality, add value, and enable sustainable innovation.
Assured and improved quality through real-time performance feedback, proactive and preventive actions, and predictive data analysis.
Pharmaceutical quality professional with a background in translational (i.e., late preclinical, early clinical) oncology research and broad FDA-regulated, GxP quality assurance experience, including oversight of a clinical autograft transplant cell therapy program (GMP), Ebola/Marburg vaccine research in non-human primates in BSL4 high containment (GLP/Animal Rule), and manufacture of drug substance/product (GMP)
Advocates a culture that prioritizes quality as a shared value; staff autonomy, training, and development; leadership authenticity and transparency; a proactive, practiced, data-driven, and risk-based continuous improvement program; established SMART Quality Solutions and ongoing training in continuous quality improvement and biomedical data management to support the integration of new technologies by the pharmaceutical industry
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