Quality Assurance and Regulatory Compliance leader leveraging over 20 years of experience in development/implementation of holistic and compliant quality management systems and innovative solutions to drive compliance, improvement, and efficiency in areas of medical device, biopharmaceutical, and aerospace industries. Proven success in building and maintaining state of the art compliant and efficiently scaled quality systems for a wide variety of company sizes and business needs.SPECIALTIES:ISO 13485, ISO 900121CFR Parts 820, 210, 211ISO 9001, AS9100, AS9115, DO178, FAASoftware Validation; 21 CFR Part 11Quality System AuditsCorrective and Preventive Action / Root Cause InvestigationSupplier ManagementProduct Development Quality AssuranceTechnical FilesRisk ManagementMedical Device Sterilization Development and Execution of Quality and Regulatory Training ProgramsProcess Improvement / Process Mappinge-QMS Configuration and Validation (MasterControl)

Cord Blood Registry (CBR) is the world’s largest newborn stem cell company entrusted by parents with storing samples from more than 500,000 children. CBR is dedicated to advancing the clinical application of cord blood and cord tissue stem cells by partnering with institutions to establish FDA-regulated clinical trials for conditions that have no cure today. • Oversight responsibility for daily operations and strategic direction for Quality Assurance Program• Management of team of Quality Assurance personnel• Responsibility for MasterControl Electronic Quality Management System: Document Control and Records, Training, Change Control, Incident Reporting, Risk Assessment, Corrective and Preventive Action, Quality Investigations, Deviations, Complaint Handling, and Nonconforming Material Reporting• Management of the Quality Assurance Inspection Program for Kit Operations• Management of the Calibration Management Program• Development and Reporting on Quality Assurance Metrics for monthly reports and Quality Management Reviews• Quality Representative for CAPA Review Board, Change Control Board, Design Review Board and Regulatory Audits• Creation of relevant training for Quality Assurance Program• Leader in driving process improvement and consistency across the organization to meet regulatory requirements and best quality practices for effective quality system management.

ScriptSave specializes in designing prescription drug benefits, which provide the most value to customers with no drug benefits, limited drug benefits, or prohibitively costly drug benefits. With over 62000 participating chain and independent retail pharmacies, ScriptSave has provided unique prescription savings programs to millions of consumers and hundreds of plan sponsors. • Responsible for promoting quality achievement and performance improvement throughout the organization while maintaining an awareness of business context return on investment (ROI) and alignment with strategic goals and objectives• Management of a team of IT QA analysts operating in an Agile environment to ensure that technology deliverables met internal and external requirements and user experience expectations • Championed the enterprise Quality Program across the organization and successfully worked with staff at all levels to implement quality principles, standards of performance and business metrics • Served as a role model for innovative thinking and service excellence within all business processes • Monitored performance by gathering relevant data and producing metrics and progress reports • Managed the technology QA team with responsibility for staff recruitment, selection, training, feedback, technical guidance, and skill development

•TES is a key provider of software and hardware for embedded systems solutions, engineering services and unique products to the Aerospace, Defense and Commercial industries. TES specializes in mission and flight critical electronic development, verification, integration, automated test equipment, and manufacturing. • Directed total quality management system programs, policies, and initiatives aligned with business objectives and goals to meet ISO 9001, AS9100, DO-178 and FAA Regulations• Responsible for identifying, analyzing, and developing improvements in productivity, quality, processes, client relationships, and customer service• Reported to top management on quality management system issues, process metrics and effectiveness, and improvement opportunities across the entire Quality System• Implementation of process-based approach to company-wide standards and practices• Oversight of integrated electronic quality management system database development• Review and release of all product documentation and final product output for regulated as well as rapid prototypes; audit of project practices• Development and management of key quality processes: Management Review, Training, Corrective and Preventive Action, Supplier Management, Customer Complaints, Document Control, Records, Nonconforming product, Internal Audits and External/Customer Audit Liaison

QUALITY SYSTEM/COMPLIANCE MANAGEMENT• Management of all regulatory (FDA, Japan, Europe, Canada), notified body, customer, and internal compliance audits for ISO 13485 aqnd 21CFR Parts 820, 210, 211 and development of post-audit corrective action plans• Management of internal audit program; developed audit tools to meet medical device and drug requirements• Consulted on all aspects of quality and regulatory compliance and assisted in all quality system activities as needed ensure effectiveness of the quality system and appropriate business planning• Developed and executed comprehensive quality system and auditor training programs • Coordinated multi-site Quality Management Review information, presentation, and follow-up activities• Managed Corrective and Preventive Action to ensure solid root cause investigation and effective action plans• Championed the development and implementation of sector-wide electronic quality information system• Initiated and completed numerous specialty projects as needed, including development of innovative regulatory compliance database to ensure compliance for country of sale• Managed coordination of efforts and reporting and mentoring of Quality Assurance Managers in 12 locationsSOFTWARE VALIDATION MANAGEMENT• Management of all software validation activities, including development of SOPs, protocols, and training programs to meet FDA 21CFR Part 11 requirementsENVIRONMENTAL MANAGEMENT • Developed and implemented Environmental Management System and associated SOPs aligned to ISO 14001• Development of innovative solutions for interdisciplinary compliance management of Quality, Safety, and Environmental Management Systems• Responsible for management of environmental permits, MSDS system, training, audits• Ongoing collaboration with Occupational Safety and Industrial Hygiene Manager • Managed corporate sustainability initiatives toward landfill elimination and energy conservation

• • Developed and executed Ethylene Oxide sterilization validations within contract sterilization facilities to meet AAMI/ISO sterilization requirements• Developed standard gas chromatography methods, validation, and subsequent monitoring for ethylene oxide residual testing to meet AAMI standards• Performed sterility and product bioburden laboratory testing to meet sterilization requirements• Reviewed and released sterilization records; consulting on impacts of sterilization deviations• Developed and implemented calibration program for sterilization laboratory