Tim Huber Email and Phone Number

• Global QA subject matter expert on Change Management, Deviation Management, Documentation and Data, Personnel Qualification• Global QA SME on a team to redesign the deviation management system and implement changes across all manufacturing sites. Support included development and delivery of training and providing support to sites prior, during and after implementation• Business lead for the project to deploy a new TrackWise instance, data warehouse, visualization and reporting processes supporting deviation, analytical investigation, and change management processes. • Provides Business QA support for all Global GMP IT systems.

• Responsible for training all new QA personnel.• Direct supervisor of Quality Assurance Specialists• Lead QA representative on inspection readiness teams for new product submissions and supports external inspections as a member of the audit support team• Local QA lead to change a dedicated API manufacturing facility into a multi-product API manufacturing• Site TrackWise leader responsible for training new Trackwise users and working with the central Trackwise groups on system enhancement projects• Site representative on the team that created global event, change, and backlog metric dashboards and centralized periodic reporting templates• Created site quality lead team metrics and responsible for monitoring and reporting site quality metrics• QA rep for various production areas (purification, utilities, and warehouse)

• Responsible for ongoing front-line daily support of Solvent Recovery, API, Intermediate, and development processes• Developed and implemented solvent recoveries processes resulting in more than 5 million dollars per year in raw material cost savings• Led tech transfer effort, process validation, and cleaning validation efforts for a API process• Supervised Lab Technicians, developed and completed performance management plans

• Building lead for SAP Implementation• Developed a new material with supplier to solve repeat process failures resulting in $20,000,000/yr cost savings• Oversaw process design efforts of a contract design company capital expansion project to double plant capacity• Led Process Hazard Reviews for new distillation and tank farm operations• Performed facility siting assessments• Developed facility start-up and commissioning plan