Dominick Villani
About Dominick Villani
Dominick Villani serves as the Vice President of Quality Assurance at Akero Therapeutics, bringing over 22 years of experience in the biotechnology and pharmaceutical sectors. His extensive background includes leadership roles at various companies, including Enable Injections and Amylin Pharmaceuticals, where he specialized in quality assurance and regulatory compliance.
Current Role at Akero Therapeutics
Dominick Villani serves as the Vice President of Quality Assurance at Akero Therapeutics since 2021. In this role, he oversees quality assurance processes and ensures compliance with regulatory standards. His leadership contributes to the company's commitment to maintaining high-quality standards in its therapeutic developments. Akero Therapeutics is located in South San Francisco, California, where Villani applies his extensive experience in the biotechnology sector.
Previous Experience in Quality Assurance
Villani has held multiple senior positions in quality assurance across various organizations. He worked at Enable Injections, LLC as the Director of Quality Assurance and Regulatory Affairs from 2015 to 2016, and later as the Vice President of Quality Assurance from 2016 to 2020. His experience also includes roles at Amylin Pharmaceuticals, where he served as Associate Director of Operations Quality Assurance from 2011 to 2013, and at Bristol-Myers Squibb, where he held positions related to quality assurance compliance.
Educational Background in Biological Sciences
Dominick Villani studied at California Lutheran University, where he earned a Bachelor of Science degree in Biological Sciences with an emphasis in Microbiology. His education spanned from 1993 to 1997, providing him with a solid foundation in biological sciences that supports his extensive career in quality assurance within the biotechnology and pharmaceutical industries.
Expertise in Quality Management Systems
Villani has over 22 years of experience in quality management within the biotechnology, pharmaceuticals, and medical device sectors. He specializes in utility management, having developed Utility System sampling plans and participated in regulatory inspections in countries such as Japan, Korea, and Taiwan. His expertise includes implementing compliant data acquisition systems and extensive knowledge in Root Cause Analysis (RCA), CAPA, and Change Control Systems.
Professional Contributions and Innovations
Throughout his career, Dominick Villani has contributed to various quality assurance initiatives. He implemented a 21 CFR Part 11 compliant Mobile Data Acquisition system for environmental monitoring, showcasing his innovative approach to data management. Additionally, he developed inspection qualification programs for media fills, emphasizing his commitment to maintaining high standards in production processes.