Managing Director
FTI Consulting, United States
Pat Shafer is a Managing Director within Health Solutions and leads the Life Sciences Regulatory and Quality practice. He is responsible for delivering services, solutions and thought leadership for pharmaceutical, biotech and medical device clients. He has 40+ years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of quality and compliance, regulatory affairs, and operations, clinical, safety and surveillance, manufacturing, supply chain, medical affairs and commercial.
Pat has worked around the world to assist clients in the development and execution of strategies that promote innovation and growth, speed to market, operational efficiency, and process excellence, and sustained regulatory compliance. Pat has worked extensively with both global, top 5 companies to optimize performance, as well as pre-revenue, and emerging life sciences companies across the value chain to build core capabilities and achieve launch readiness. He works regularly with Private Equity and M&A teams to support pre-deal regulatory, quality and compliance due diligence as well as post-merger integration.
Pat is a strategic advisor to the FDA, co-leading collaboration efforts among the FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry as part of the FDA’s Case for Quality, including defining quality metrics, identifying leading practices for quality management review, and developing a playbook of leading practices for quality and corporate leadership.
Before joining FTI Consulting, Pat served in leadership roles at Grant Thornton and Deloitte Consulting. Prior to his time at Deloitte, he led a contracting consultancy, helping legal and contracting organizations with competency model development and process and technology optimization. He started his career in communications, knowledge management, and interactive learning, supporting professional development in the areas of finance, ethics and compliance, contract management and quality.
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