Roland (T) Cucinella, Asq Cqa
About Roland (T) Cucinella, Asq Cqa
Roland (T) Cucinella is the Director of Quality, Systems & Compliance for Gene Therapy at StrideBio, Inc. He has extensive experience in quality assurance and compliance across various organizations, including KBI Biopharma and Bristol-Myers Squibb, and has successfully managed multiple regulatory inspections throughout his career.
Current Role at StrideBio
Roland Cucinella serves as the Director of Quality, Systems & Compliance for Gene Therapy at StrideBio, Inc. He has held this position since 2021 in Research Triangle Park, NC. In this role, he oversees quality systems and compliance initiatives, ensuring adherence to industry regulations and standards within the gene therapy sector.
Previous Experience at KBI Biopharma
Cucinella has extensive experience at KBI Biopharma, where he worked in various capacities. He served as Associate Director of QA Compliance from 2017 to 2019, Director of Quality Assurance Operations for a brief period in 2021, and Director of Global Quality Compliance from 2019 to 2021. His roles involved managing quality assurance operations and compliance across multiple projects.
Background in Quality Assurance and Compliance
Cucinella has a solid background in quality assurance and compliance, having worked at notable companies such as Bristol-Myers Squibb, TOLMAR Inc., and Amgen. His role as Quality & Regulatory Compliance Program Lead at Bristol-Myers Squibb lasted five years, where he focused on regulatory compliance programs. He also facilitated regulatory inspections across multiple countries.
Education and Professional Development
Cucinella studied at Western Governors University, focusing on Business Management, Healthcare, and Life Sciences, with an emphasis on Healthcare & Life Sciences Management. He also attended Chaffey College, where he studied Biological and Physical Sciences. He has completed PDA Quality Culture training and holds a Yellow Belt certification in biologics.
Achievements in Quality Risk Management
Cucinella has expertise in developing, implementing, and managing ICH Q9 Quality Risk Management programs. Throughout his career, he has successfully managed three Pre-Approval Inspections (PAI) and has implemented quality culture programs within organizations.