Charles Koon (“Chuck”), Head of Global Operations Auditing, Clinical Quality and Regulatory Intelligence for Viatris, has over 29 years of experience in the pharmaceutical industry. He has served in various capacities within site and global quality functions and played a fundamental role in transitioning Legacy Mylan from a U.S.-focused company to a global organization. Since Mylan’s transition to Viatris, Chuck has lead his team to achieve the goal of delivering increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance, along with striving towards empowering people worldwide to live healthier at every stage of life.
Beginning his career in 1992 as a Quality Control Chemist with Mylan Pharmaceuticals, he has held numerous managerial roles of increasing responsibility over the years throughout Quality Operations. As Mylan progressed into a global organization, Chuck was integral in the vision and development of Global Quality including operational, compliance, and systems development functions. This included development of the organizational structure, mapping of key systems and processes, and implementation and oversight of globally harmonized systems such as complaints management, internal and external cGMP auditing, change control, and investigations.
In 2016, Chuck was appointed as Head of Global Operations Auditing, Clinical Quality and Regulatory Intelligence for Viatris. Chuck had previously led these departments for Legacy Mylan since inception. For Viatris, he will continue to manage an internationally-based team with specialties in GMP, GCP, GLP, GPvP, GDP, EHS, and Regulatory Affairs compliance with a focus on standardized, coordinated, and objective auditing services designed to evaluate Viatris’ operations related to compliance with regulations, internal policies, best practices, and industry standards.
In the area of Regulatory Intelligence, Chuck oversees the development and delivery of consistent and standardized adult learning on global policies, corporate training initiatives, industry trends identified via regulatory intelligence, and quality culture.
In addition to his current responsibilities, Chuck collaborates with the Global Social Responsibility team to ensure that the most accurate data is captured and reflected in the annual GSR submission. Also, he has participated in the FDA Generic Drug User Fee (GDUFA) development process, been a key member in supporting major due diligence projects, and continues to be involved in industry-leading efforts to establish one global high quality standard for all Viatris products, raise quality standards for all drug manufacturers globally, and expand the world’s access to affordable, quality medicines for patients worldwide
He holds both Bachelor of Science and Master of Science degrees from West Virginia University.