John Kovach
About John Kovach
John Kovach serves as the Senior Audit Manager for Quality Systems and Compliance at Deciphera Pharmaceuticals, bringing over forty years of experience in quality assurance and compliance auditing within the pharmaceutical and biotechnology sectors.
Work at Deciphera Pharmaceuticals
John Kovach has been serving as the Senior Audit Manager for Quality Systems and Compliance at Deciphera Pharmaceuticals since 2021. His role involves overseeing quality assurance and compliance auditing within the organization. He operates from Waltham, Massachusetts, and has contributed to the company's commitment to maintaining high standards in drug manufacturing and compliance.
Previous Experience in the Pharmaceutical Industry
Prior to his current position, John Kovach held several roles in the pharmaceutical industry. He worked at Supernus Pharmaceuticals, Inc. as Associate Director of Quality Assurance for seven months in 2020. He also served as Senior Manager of Corporate Compliance and Auditing at Aptuit, Inc. from 2010 to 2011. His experience includes a six-year tenure at US WorldMeds as Quality Compliance Manager and a seven-year role at Eli Lilly and Company as Associate Senior Quality Assurance Consultant.
Education and Expertise
John Kovach holds a Bachelor of Science degree from Indiana University of Pennsylvania, where he studied from 1977 to 1980. He also attended Salisbury University from 1974 to 1977. His expertise encompasses quality assurance oversight, compliance auditing, technical transfer, and process validation. He has over forty years of experience in the pharmaceutical and biotechnology sectors.
Specialization in Quality Assurance and Compliance
John Kovach specializes in quality assurance oversight of contracted drug manufacturing operations and compliance auditing. His skill set includes equipment qualification, documentation and data management, and quality oversight of contract manufacturing operations. He has participated in the implementation and validation of electronic Quality Management System tools, such as Veeva Vault.
Involvement in Compliance and Training
Throughout his career, John Kovach has been involved in various compliance-related activities, including supplier management, training material development, and Consent Decree remediation. He has also managed change control and deviation management processes, ensuring adherence to regulatory standards in the pharmaceutical industry.