Integration of technical operations and quality teams to build site unification

Abstract

Novartis International A.G. is well known for their effective research and development of life-changing pharmaceuticals, and in 2006, Novartis bought Chiron Corporation, thereby diversifying their portfolio with a vaccines and diagnostics division. Novartis Vaccines & Diagnostics (NV&D) is dedicated to producing vaccines and diagnostics tools at the highest quality and lowest cost. This thesis is from a six-month internship that explores the Novartis Vaccine's Holly Springs, North Carolina flu-cell culture facility to assist management in better understanding the Novartis' Innovation, Quality, and Productive (IQP) system on the organization. This particular site employs approximately 350 full-time individuals and 150 contractors. The Holly Springs' facility is designed to manufacture and fill 50 million doses of seasonal influenza vaccine, and 150 million doses in the event of a pandemic (with the help of a dose sparing adjuvant). All processes, from incoming raw materials to syringe fill and finish, must be conducted at this site in order to meet a United States mandate for emergency readiness in the event of a pandemic. The facility is well on its way to finalizing the manufacturing process, installing all the production equipment, and hiring staff, however, all start ups experience difficulties and this is no different from Novartis. The site, in particular is experiencing many difficulties in their raw material release process. . NV&D management recognized the need to implement their IQP project improvement system to address the disruptions that are impacting their scheduled readiness plan. [Figure 1 displayed] Figure 1: Causal Feedback Loop of Process Improvement on Process Performance] The approach for this project and thesis will be a mix of Novartis' IQP department, quality management, and technical operations methodologies in order to fully understand the current state of the raw material release process and identify gaps within the process. Combining the raw material release project with the theories of system dynamics, Novartis can better understand the impact of their Innovation, Quality, and Productive system at varying organizational levels. The Figure to the right demonstrates the impact of process improvement on overall process performance.