Jim Walter

Jim Walter has extensive experience in the field of quality operations and management. Jim currently serves as the Director of Quality Operations at Cue Health, where they are responsible for managing the day-to-day operations of the Quality function. In this role, they focus on product release, equipment control, supplier management, and quality engineering. Jim also contributes to the organization's maturity by transitioning from Emergency Use Authorization (EUA) to regulated production efforts and improving data collection and metrics reporting processes. Additionally, they support the integration and roll-out of a Manufacturing Execution System (MES) to enhance efficiency.

Prior to joining Cue Health, Jim worked as the Associate Director of Device Quality at INOVIO Pharmaceuticals, Inc. In this position, they led a team responsible for executing the Quality Management System activities. Jim ensured compliance with regulatory standards and spearheaded improvement initiatives for quality documents and processes across the R&D, Clinical, and Operations teams. Jim also played a key role in implementing an electronic Quality Management System (eQMS) to streamline and enhance visibility in various processes.

Before their tenure at INOVIO Pharmaceuticals, Jim held multiple roles at Sotera Wireless, Inc. As the Director of Operations, they oversaw various business units, including Materials/Supply Chain, Facilities, Manufacturing, Quality, and Regulatory. Jim maintained adherence to regulatory standards and ensured key business deliverables were met. Jim also served as the Director of Quality and Regulatory, where they executed quality and regulatory functions to maintain certifications and support the customer base. Additionally, they worked as a Quality Manager and Senior Quality Engineer, where they collaborated with suppliers and internal resources to meet material availability targets and maintain product quality.

Prior to joining Sotera Wireless, Inc., Jim held the position of Director of Operations at Bioserv America. Here, they led manufacturing and facilities teams, focusing on operational execution, cost minimization, and team development. Jim successfully guided the company through a Chapter 11 process, leading to profitability and closure of bankruptcy.

Jim's earlier experience includes managerial roles at Illumina and NextPharma (Bioserv). At Illumina, they served as the Manager of Reagent Production, overseeing daily operations for filling and packaging reagents. Jim also worked as a Supervisor in Production. At NextPharma (Bioserv), they served as the Sr. Manager of Supply Chain and Logistics, overseeing material flow and administration of facility issues. Jim also served as the Manager of Materials and Facilities and the Device Manufacturing Manager.

Jim began their career as a Manufacturing Scientist at Serologicals and a Research Associate at Applied Hydrogel Technologies.

Overall, Jim Walter's work experience demonstrates their expertise in quality operations, regulatory compliance, team management, and process improvement. Jim has successfully led organizations through various challenges and has a track record of driving efficiency and meeting key objectives.

Jim Walter completed their Bachelor of Science degree in Biotechnology from Worcester Polytechnic Institute in the years 1996 to 2000. Later, they pursued their Master of Business Administration (MBA) from the same institution between 2008 and 2011.