• Design and Implement an ISO 9001:2015 and FDA 21 CFR 211 compliant quality management system• Manages organizational change and improvement initiatives, in accordance with goals and priorities selected by the President and CEO, in order to improve operational efficiency, reduce costs, and/or improve regulatory compliance.• Facilitates, leads, and monitors project teams, as necessary, to ensure improvement initiatives are aligned with executive management goals and are value added.• Ensures project cost, schedule, and quality goals are achieved.• Serves as system administrator for electronic systems relating to quality, regulatory affairs, and operations (ComplianceWire, MasterControl, FDA ESG/Regulatory Submissions, and others as needed).

•Manages organizational change and improvement initiatives, in accordance with goals and priorities selected by the President and CEO, in order to improve operational efficiency, reduce costs, and/or improve regulatory compliance.• Facilitates, leads, and monitors project teams, as necessary, to ensure improvement initiatives are aligned with executive management goals and are value added.• Ensures project cost, schedule, and quality goals are achieved.• Serves as system administrator for electronic systems relating to quality, regulatory affairs, and operations (ComplianceWire, MasterControl, FDA ESG/Regulatory Submissions, and others as needed).

Assist with the development and implementation of a 21 CFR 210 and 211 compliant quality system to manufacture FDA regulated RNA-based cancer therapeutics.

Quality:• Managed Quality Management System (QMS) in compliance with FDA Quality System Regulation (21CFR 820), ISO 9001, AS9100, and customer requirements.• Served as management representative and led management reviews. Successfully established metrics for tracking QMS performance relative to organizational goals and AS9100 requirements.• Led initial quality system certification to AS9100 (aerospace QMS requirements). Company was certified after first audit with only minor findings.• Maintained ISO 9001 and AS9100 certification and led external audits (FDA, ISO, AS, and customer). Reduced external audit findings from an average of six findings per audit to 0-1 findings per audit. Certification and approved vendor status were attained and retained after all audits.• Served as chairman of risk management, material review, and CAPA boards.• Managed and developed quality department employees.• Approved product batch records and generated acceptance data packages.• Developed training programs and conducted training.• Managed internal audit program. Completed all audits on time.• Served as quality representative (lead) on major aerospace contracts for NASA and commercial aerospace companies. Safety:• Managed corporate safety program, including development and implementation of safety and health plan, hazard assessments, audit program, and laboratory safety plans.• Managed lab safety managers.• Established performance metrics, monitored performance, and lead safety reviews with management.Industrial Security:• Managed industrial security program in compliance with Department of Defense (DoD) Directive 5220.22-M National Industrial Security Program Operation Manual for contract work involving government classified information.• Developed and maintained security manual in compliance with DoD regulation, conducted training, and facilitated employee security clearances. Improved clearance processing time by >30%.• Led DoD and FBI audits.