• Responsible for 6 FTEs and 14 contractors for GMP and GLP operations at multiple locations.• Oversight includes Equipment, analytical instrument, utilities, cleaning validation, CSV, and periodic review/revalidation. • Documentation includes Commissioning protocol, URS, risk assessment, Config specification, IOQ, PQ, RTM, Validation Master Plans, Execution plans, SOP's, policies, and validation reports.• PM for GMP/GLP lab capacity increase project (>300 systems including automated lab systems).• Completed on time completion of manufacturing and laboratory capacity optimization project by managing CQV activities and scheduling during height of Covid-19• PM for new Research/Tech Dev laboratory (>700 systems including automated lab systems.• Implemented DI remediation and controls with cross functional team.• Implemented ValGenesis

Position is responsible for validation compliance leadership at the Branchburg, NJ site by balancing schedule, quality, and cost containment while maintaining a focus on business owner satisfaction. Manage and mentored a staff of sixteen (16) full time employees providing support for a two suite multi-product manufacturing buildings and several other support buildings. Validation oversight includes: Multi-product operations, cleaning, shipping, process, utilities, computer systems, equipment, commissioning, and maintenance validation activities using the following documentation: Installation/Operational Qualifications, Performance Qualifications, User Requirement Specification, Functional Specifications, FAT, SAT, Validation Master Plans, SOP's, and validation reports.Successfully completed regulatory inspections for four (4) products with FDA, EMA, Canada, Germany, Japan, Turkey, Brazil, Mexico, TGA (Australia) and site inspections.