Susan Mozgai CQA, CQM/OE, SSGB, CPGP

Managing Consultant, Tunnell Consulting, Inc.

Susan has over 20 years of Life Sciences experience including discovery, research and development, technical transfer and commercialization of primarily vaccines, prescription and consumer drugs. Specific expertise facilitating and managing programs in quality management and regulatory compliance, risk management, operational and organizational excellence, designing, and implementing manufacturing and quality management systems in compliance with regulations. Susan has expertise as a quality leader running the business as well as leading numerous transformation improvement projects with varying complexity for global scope to specific site deliverables within operations, regulatory, R&D, manufacturing, quality control and assurance environments through all phases of the product lifecycle. She has led many remediation and continuous improvement teams, championed company-wide internal audit and inspection readiness programs for a major pharmaceutical and medical device companies, and led implementation of IT enterprise tools to support automation of business processes during operational excellence and transformation programs. Extensive change management experience leading corporate driven transformation to operational level due to M&A or regulatory actions such as warning letters and consent decrees. Susan has a BS in Microbiology, is a senior member of American Society for Quality (ASQ) and ASQ certified Pharmaceutical GMP Professional, Quality Auditor, Manager of Quality/Organizational Effectiveness and Six Sigma Green Belt.


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