Lead the development from inception and execution of the quality management system for StatLab Medical Products.-Lead the development, implementation, and monitoring of the quality system to meet ISO 13485 and 21 CFR Part 820 regulatory requirements and organizational goals.-Continuously improved quality documentation-Analyzed operations data to identify areas of non-conformance or opportunities for improvement, develop inspection programs to ensure materials meet customer and organizational specifications -Manage root cause analysis, and facilitate corrective and preventive action program to resolve product and process defects efficiently and effectively-Directed all Quality Assurance and Quality Control activities for the firm-Developed and implemented environmental quality strategies; EHS initiatives for the firm-Executed all regulatory updates and managed agency and customer audits for the firm

• Responsible for Program Performance and Customer Satisfaction for portfolio of aerospace and defense customers.• Design, Plan, and Build an Effective Operational and Service Delivery Team for all assigned programs.• Set Program Level Strategies, Goals and Objectives to drive Account Retention and Development. • Execute on New and Expanding Service Product Strategies.• Strategic sales and business development efforts across assigned accounts. Engage with senior level customer and industry contacts on business performance and growth.

Planned and directed the organization’s operations, objectives and initiatives delivering accredited ISO 9001, AS 9100C and ISO 14001 certifications. Developed policies and procedures for operational processes in order to ensure optimization and compliance with established standards and regulations. Managed organization’s certification program(s) and performed oversight of the Quality Management System. Developed business growth strategies and marketing platforms. Provided financial forecasting to support due diligence by acquirer and managed transition to acquirer post divestiture.• Managed organization’s certification program, performed technical reviews of auditors and audit output• Provided technical subject matter expertise• Performed oversight functions and evaluated results of overall operations• Redesigned company policies and developed long-range goals and objectives• Managed divestiture of business providing future business potential and transitioned operations to acquirer

• Responsible for new lead generation, contracting and strategic partnership development.• Implemented programs, policies and procedures to ensure regulatory compliance.• Represented firm at national conferences.• Developed innovative sales and marketing strategies and material for the organization.• Managed staff in customer development, dealer relations and account servicing.

• Presenter of quality program during regulatory inspections and audits. Presented data, defended facility programs, conducted investigations and supported preparation of audit responses.• Role within Amgen Program Management and Technical Operations group which was directed at leading operational excellence initiatives and lean manufacturing deployment within the department.• System Owner of Environmental and Utility Monitoring Program for clinical manufacturing maintaining full program compliance with multiple regulatory agencies (FDA, EMEA) and standard regulations (CFR, ISO, USP).• Acted as program Subject Matter Expert; made and communicated key decisions related to the EM program on behalf of clinical manufacturing.• Served as Change Leader for new initiatives included new facility characterization. Developed project plans, assembled team and directed implementation including reporting. • Evaluated regulatory and pharmacopeia requirements in the authorship of operational standards.• Proactively assessed the program for continuous improvement and innovation in all areas to ensure compliance is maintained and tasks are streamlined.• Designed, documented and launched quality system trending strategy for microorganisms in clinical plants to determine trends or atypical process behavior.• Maintained site program policies and procedures. Ensured that operating procedures aligned with Global Standards and current regulatory expectations. Designed and revised programs and procedures as necessary.

• Annual planning and process execution of 12+ million dollar budget engaging in budget management tool generation and finance strategic decision-making.• Developed and maintained capacity models and reports for accurate resource planning.• Maintained timelines for departmental projects and technology tool deployment.• Ensured operational alignment across the function through technology tools integration.• Served as team project manager for web based eLearning development and cross functional business practice development.• Developed, tracked, analyzed and reported functional area metrics and performance measures.• Designed programs for SOP compliance monitoring and a comprehensive budget monitoring tool via Access.

• Launched and functioned as program lead for NC/CAPA activities for Amgen cell bank operations employing Six Sigma and DMAIC investigation tactics.• Functioned as Responsible System Owner for cell bank equipment encompassing work order facilitation, compliance/quality assessments and validation execution (IQ/OQ/PQ).• Designed, developed and implemented the cell bank storage stability monitoring program which encompassed initial assay design, execution, technical reporting and data archiving.• Acted as cell bank lead on IND and NDA submissions for clinical candidates.• Broadened knowledge of cell culture processes for CHO and microbial cell line systems.• Effective in providing cell culture process knowledge in support of regulatory filings, inspection responses and high-level risk assessments.

• Performed all aspects of production associated with development of the ELAD®, extracorporeal liver assist device, a state of the art artificial liver device. • Performed cell culture assays to analyze cell growth and proliferation; monitored and operated dynamic cell expansion activities using automated bioreactor units. • Class 100,000 and Class 100 clean room experience, aseptic technique experience, and GMP compliance. • Prepared Standard Operating Procedures, change control documents, research and engineering protocols, final research reports, and validation documents. • Compiled and analyzed data, making key process improvement decisions pertaining to protein production in cell culture.

-Cornea Tissue Procurement for transplant.-Lab Maintenance and sterilization coordination.-Tissue evaluation for transplant placement suitability.