Date of Conferral

8-25-2025

Degree

Doctor of Business Administration (D.B.A.)

School

Management

Advisor

Irene Williams

Abstract

Failure to comply with the U.S. Food and Drug Administration (FDA) quality regulations can lead to enforcement actions for the biotechnology (biotech) industry. Noncompliant regulatory strategies have the potential for adverse medical outcomes for patients. As a result, managers in the biotech industry are concerned about ensuring compliance to avoid adverse medical outcomes for patients and sustain business operations. Grounded in Deming’s total quality management concept, the purpose of this qualitative pragmatic inquiry project was to explore effective quality management strategies that managers in the biotech industry use to develop and continuously improve compliant regulatoryQuality Federal Regulations processes to meet the FDA quality federal regulations. The participants were six biotech managers with five or more years of experience in the biotech industry from the central region of the United States. Data were collected using semistructured interviews and public data from the U.S. FDA data dashboard of enforcement actions. Through Braun and Clarke’s thematic analysis, four major themes emerged: understanding U.S. FDA enforcement actions and the business consequences of poor regulatory compliance, fostering a quality culture, providing leadership support and engagement at all levels, and accelerating education and experience. A key recommendation is for biotech managers to create a company-specific risk-based compliance improvement plan. Implications for positive social change include the potential to reduce FDA enforcement actions, reduce market shortages, reduce treatment delays, and increase patient safety within the community.

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