Pharmaceutical Quality Systems (PQS)ISOICHQ10FDA 21 CFR 210 211FDA 21 CFR 820

Oversee the shop floor of 30 direct and indirect reports on the shop floor that includes two Supervisors, Senior Production Technicians, Equipment Technicians and Production technicians. Plan and lead to meet and exceed goals. Positive influence on the shop floor. Primary department functions include the inspection, labeling, serialization and packaging of vaccines shipped globally• Effective communication skills; cross-functional team member and leader• Track, trend and drive +QDCI; Safety, Quality, Delivery, Cost, Involvement • Manage ~$50,000 annual budget• Develop team members and support growth mindset to meet and exceed business goals• Right the First Time change leader to reduce human error and cycle time• Line 4 Lean Design workshop and Line 2 SMED Event workshop team member for new Syringe and Vial packaging lines• Best in class OEE performance, increased overall equipment effectiveness from 25% to 40%

Corporate Quality role responsible for tracking and trending product quality complaints globally • Communicate with internal and external customers • SAP management and data analysis• Cross-functional collaboration with key stakeholders that includes internal project management teams, site leadership and external customers• SPC (statistical process control)

Provide technical expertise and hands on application of the formulation, manufacturing and packaging of controlled and non-controlled pharmaceutical products in the laboratory and R&D environment • Project management includes scaling products from the product development laboratory and R&D equipment environment for preparation of FDA submission; Scale up to commercial manufacturing and packaging • Test equipment, recipes, and excipients• Author, review and approve procedures and documentation for product development and commercial manufacturing

• Design, implement and own Visual Management and Process Confirmation for manufacturing and packaging • Lead Technical support of process improvements in manufacturing and packaging; cost savings initiatives, process improvements, procedural enhancements• Management of Change Controls; see through corrective actions and efficiency reviews• Strategic Thinker; cross-functional leader to develop training plans to ensure adequate and competent staff; Prepare and recommend operating plans and monitor results• Author, review and approve batch records and standard operating procedures • Own biennial reviews for standard operating procedures • Provides guidance to ensure compliance with cGMP regulations and a positive influence on others as a knowledge base and resource in Pharmaceutical manufacturing and packaging

• Lead, manage and coach a team of sixteen (16) direct reports, and additional 16 indirect reports in Finished Solid Dosage Form operations including Tableting/Compression, Spray Coating and Encapsulation processes• Performance tracking and training of (30+) operators that includes Metrics, KPI’s and OEE• Improved Right the First initiatives from 80%, continuous results of 90%• Schedule adherence and commitment’s goal of 98%, continuous results of 99.4%• Improved Run Time performance in (2) years from 80% to 95%-100%• Improved OEE from 50% to 55%-60% • Improved changeovers 95-100%• Quality reviews of documentation in accordance with GMP• CAPA assignments and implementation• Initiate investigations related to deviations, 5W2H, root cause, fishbone, corrective action

• SME in Tableting/Compression, Coating, Encapsulation• Group Leader of ~15 peers• Manage quality incidents and write investigations• Cross-trained to dispensing, granulation, LCO

• Operation, breakdown, setup, troubleshoot/repair of manufacturing/packaging/R&D equipment• Document and Review batch records for quality assurance prior to final quality review• Follow all cGMP and compliance procedures