Utilized lean six sigma matrix methodology for Project/Change Management with construction and implementation of business planning and process improvements that ensured continuity in the manufacturing and global transportation of marrow products. Headed Quality Assurance team using Gap Analysis and DMAIC tools in pursuit of CAP accreditation while applying industry best practices/safety standards (FDA, HIPAA), organizational policies and procedures, resulting in sustained regulatory compliance. Investigated research literature for reviewing outcomes, forecasting, and trending treatments for blood diseases. Applied Validation-Innovation-Measure-Feedback to improve processes. Accountable for 30 employees. • Managed $750,000 KitMaker enterprise: Consistently surpassed annual kit fulfillment goals, increased revenues, and helped save lives. Collected/analyzed and interpreted data. • Selected to create and deliver cross-functional training sessions on global compliance of federal regulations, which resulted in 100% elimination of compliance violations/fines and increased integrity of donor samples. Collaborated with vendors, department managers, RN, MD/PhD, VP, and Directors. • Applied UXD and Agile methodologies to improve software experience with end users; expanded KitMaker services by 25%.• Designed/implemented documentation control system; met regulatory compliance/business tracking needs. • Applied SIPOC and other DMAIC tools to lead project that centralized services, resulted cost saving of $80,000/enhanced quality. • Utilized RACI matrix, SIPOC, analytic metrics, and other tools to spearhead automated systems project; reduced staff time by 15%; saved $15,000. • Prudent budget management ($5M): Kept department within budget (full P&L). • Implemented lean process improvement initiatives resulting in 25% faster production/assembly of blood collection kits, which increased global customer satisfaction due to consistent quality.

High energy Operations Supervisor accountable for eight staff at FDA/HIPAA regulated facility in purification of islets of Langerhans for human transplant that cured diabetes. Selected as Quality Assurance liaison and change agent champion between Islet Program and regulatory team due to commitment to patient safety, operational superiority, financial acumen (budgeting), and adaptability/flexibility in leadership. As change agent – persuaded Islet Program in pursuit of regulatory compliance. Project Management: designed/implemented performance improvements & risk management resulting in faster/safer delivery of islets to operating room. Applied Validation-Innovation-Measure-Feedback to improve processes.• Collaborated with cross-functional medical teams (RN, MD, PhD) to ensure Quality Assurance (QA) and operational activities carried out in timely delivery of islets to operating room. • Utilized RACI, SIPOC, analytic metrics and other tools to collect and analyze data resulted in design/implementation of lean process improvement plans that increased productivity by 35%; saved $250,000. • Collected and analyzed data; designed and implemented lean process improvement plans that increased productivity by 35%. • Lean budget management: Kept Program within $3M supplies budget (full P&L). • Led team to increase compliance in FDA regulations by 50%, avoided fines. • Communicated Quality Assurance issues to Program principle investigator and followed up with site personnel, which kept team in compliance and prevented delays in production schedule.

Developed molecular assays for start¬up medical technology/clinical lab, trained/mentored diverse groups of students/staff; performed clinical assays in high-volume, fast-paced clinical lab, and collected/interpreted data and wrote reports for the Lab Director. • Managed day-to-day workflows: Solved problems and ensured business continuity while training students/doctors/Post¬docs state-of-the-art techniques in molecular/medical technology. • Processed human blood samples according to federal regulations; tested samples via an array of molecular DNA/RNA/protein assays in order to save lives/improve quality of patients’ health. • Drove regulatory compliance in FDA regulated clinical lab as part of risk management while ensuring passage of regulatory audits for the department.