Responsible for coordinating systems, strategy, and cultural integrations towards the manufacturing Compliance team in Fractionation and Purification.- Lead compliance team of investigators conducting manufacturing investigations (Events, CAPA, OOXs, OOTs) for Fractionation and Purification.- Support/Lead manufacturing compliance gap reduction, event reduction, Right First Time initiatives, internal/external regulatory inspections, compliance projects.

Manage bulk purification and aseptic processing manufacturing departments of 130 employees and $18.5MM budget- Successful production total of 421 MAU of product and Building 1 Exit/Decommissioning.- Ensure products are provided to customers on time so that product quality, yield, operating costs and process efficiencies are met- Responsible for assuring compliances to all regulatory requirements – FDA, OSHA, etc- Increased process yield and absorption by 10% via process improvement project for clarification filtration change.- Achieved reduction in spend for cleaning materials and non-BOM items through Kaizen and Kanban of inventory management.

Responsible for support with daily Bulk and Fill Finish Manufacturing Operations- Led and coordinate completion of Customer Complaints and Inter Plant Shipping Order Corrective Action Report (ICAR), Complaints (Non-medical, Adverse Events), CAPA reviews (Events and OOLs)- Review and approve Protocols, Studies, SOPs, Batch Record revisions- Manage and lead major Change Control projects (Process improvement (Q-Elution Discard volume), compliance gaps (NF), mentor/sponsor new Change Control owners- Coordinate and manage Stability requirementsPresent, escort and support for various audit internal/external inspections (FDA)- Develop Quality metrics for Events QIT 1, QA QIT 0, Leading Daily Improvements (LDI) and Leader Standard Work (LSW)

Lead critical OOL, OOS CAPA investigation teams in identifying root cause and implementation of corrective actions. Led successful High CAPA for Building 1 Fractionation with 100% effectiveness. Improve OOL trending and Trackwise 8 rule sets. Support and develop OOL, OOS inspection review slide decks. Review and approve critical investigations. Mentor and develop investigation staff on problem solving skills. Drive continuous improvement with OOL standard work for initiations and trending. Streamline and implement dashboard scorecards for Bioburden data for Monthly Management Review.

Lead and manage team performing OOL, OOS CAPA investigations. Developed and enhanced Quality Working Teams for bioburden. Facilitate and lead QC tactical meeting for management and completion of external and internal commitments. Support external and internal inspections. Review and approve lab related Events. Provide quality compliance support for QC lab events. Participate in monthly lab GEMBAs.

Scheduling and planning for Pharma manufacturing utilizing capacity, budget and forecasting models to coordinate and ensure meeting fulfillment requirements- Develop and streamline current scheduling process with long range goals to ensure alignment between department and LA plant with objectives and goals (Fulfillment, Quality, Financials (absorption), Operations)- Develop and model Budget and Forecast for Pharma manufacturing BU- VIP $265K for AHFM filling absorption- Analyze MRP system areas to improve and ensure alignment of BOM manufacturing processes with regulatory licensed and approved geographies- Led AS400 to JDE Enterprise One ERP/MRP system implementation and training team

Pharma Manufacturing production planner;Developed working Forecast and Budget models for Manufacturing absorption

- Developed Materials Requirement Planning operating system to streamline with real time production environment- Maintain and schedule conjugation production to be executed- Lead cross functional team to align conjugation processes from different methodologies, product lines and techniques in order to consolidate processes for standard work- Establish primary and alternate supplier vendors for purchasing of raw materials to ensure availability of raw materials for production of finished goods