Thomas Hughes Email & Phone Number

Washington, Dc, Us

•Design, implement, and supervise ORAs Quality Management System (QMS) including writing, reviewing, and approving policies, procedures (SOPs), guidance, and job aids; supervise Quality System Manager•Manage Division and Branch Managers responsible for ORA’s programmatic training for FDA Investigators GMP (manufacturing), GLP (laboratory), and GCP (BIMO clinical) Inspections•Manage and monitor multimillion-dollar training budget •Design, develop, implement, and maintain OTEDs records management system including supervising Records Coordinator and Staff•Authored Training Officer Handbook, co-authored Student Handbook. Co-authored Records Management handbook. • Delivered virtual & instructor-led training on Training•Graduated from the Federal Executive Institute: Leadership for a Democratic Society addressing OPM’s SES Executive Core Qualifications (ECQs (2022))

•Managed day to day operations of Sanofi’s Global Quality Audit Training Program•Represented Global Quality Audit department during US and international initiatives•Poster Session: Process Improvement Initiatives for Sanofi’s Global Quality Audit Extended Council

Rockville, Maryland

Developed Training and Certification Programs•Led ORA’s Investigator and Clinical Analyst Certification Programso Developed personnel certification program towards ISO Standard 17024: Conformity assessment--General requirements for bodies operating certification of personso Designed new certification programs in Clinical Bioresearch Monitoring (BIMO), Low Acid Canned Food/Acidified Food, and Import Operationso Redesigned Seafood and Medical Device Investigator Certification Programs•Reviewed and approved training courses for CEUs (Continuing Education Units (Credits))oAccredited under ANSI-IACET Standard 1-2013 by the International Association for Continuing Education and Training (IACET) as an authorized provider of Continuing Education Units•Applied ADDIE (Analysis, Design, Development, Implementation, and Evaluation) model to training course development and delivery:o Oversaw and conducted job analyses and job task analyseso Monitored design and development of courses and end of course assessmentso Evaluated training effectivenessManagement of Staff•Managed six (6) first-line supervisors of a staff of 80+ employees responsible the design, development, and delivery of learning events and certification programs•Supervised the Certification Team 10+ employees and Division’s Quality System Team•Responsible for day-to-day operations for the design, development, and delivery of: o Developed new/revised existing policies, procedures (SOPs) as neededo Staff training/mentoringo Conducted employee performance evaluations/personnel actionso Reviewed and approve travel, developed Division annual budgets

Rockville, Maryland

Developed Training and Certification Programs•Maintained knowledge of ANSI-IACET, ASTM, and ISO Standards related to training and personnel certification•Supervised development, administration, and analysis of job-knowledge tests. Certification Team actively develops tests in the food and drug program areas:o Test development working with subject matter experts (SMEs) conducting job task analyses, competency analyses, identifying eligibility requirements, test item writing, test item review, creating test forms, standard setting, equating, and recertification •Supervised administration of performance-based certification programso Certification Team was responsible for reviewing and approving applications, coordinating assessment activities, and reviewing and approving recertification activities of certified persons. Certification programs include: •FDA Drug Investigators (Levels 1-3)•FDA GCP and GLP BIMO Investigators•FDA Blood Bank and Plasma Center Investigators•FDA Cooperative Program Investigators (Milk, Retail, Shellfish)•FDA Medical Device InvestigatorsMaintained accreditation of ORA’s New Hire Investigator Training Program under ASTM Standard E 2659-09: Standard Practice for Certificate Programso Implemented, tracked and trended program evaluationso Implemented quality improvement initiatives for certificate programo Reviewed and revised Division Standard Operating Procedures (SOPs)o Reviewed, approved and implemented corrective and preventive actions (CAPA)Management of Staff•Supervised 9 employees (local and at-a-distance) on the Certification Team who designed, developed, and delivered national personnel certification programs for ORA Field Investigators and Analysts:o Developed position descriptions, job announcementso Recruited, hired, and retained staffo Planned, directed, reviewed, and adjusted staff workloado Provided direct mentoring/training; established and conducted employee evaluations o Managed staff budget

Rockville, Maryland

Training/Project Management Experience•Led inter-Agency team of subject matter experts (SMEs) in the design, development, implementation, and continuous improvement of ORA’s Pharmaceutical Inspectorate Training Program•Lead Project Manager that coordinated the design, development, delivery, and continuous improvement efforts of FDA’s Drug Investigator/Pharmaceutical Inspectorate National Training Programo Design and deliver classroom-based training course content and assessments in pharmaceutical GMPs (21 CFR 210 and 211) for FDA investigators, analysts, and compliance officers•Redesigned classroom-based training courses including: Basic Drug School, Industrial Sterilization, Active Pharmaceutical Ingredient Manufacturing, and Pre-Approval Inspectionso Led team of FDA SMEs in the design and delivery of FDA’s Pharmaceutical Inspectorate Training Program. o Designed and delivered new distance learning programs in pharmaceutical GMPs for FDA investigators, analysts, and compliance officers. Lead Project Manager, participate on teams to design and develop new performance metrics for FDA/ORA Investigators in Bioresearch Monitoring (BIMO) o Initiated the design of a certification programs based on ORA/DHRD standards for investigators conducting inspections and investigations in BIMOCertification Team Experience•Led the accreditation of New Hire Investigator Training Program by the American National Standards Institute (ANSI) under ASTM Standard E 2659-09: Standard Practice for Certificate Programs. FDA/ORA was the first Federal Government agency accredited by ANSI under this standard in January 2010.o Implemented program evaluationo Developed a quality management system for certificate program including policies and procedures and quality tools to address document control, record control, corrective actions, preventive actions, internal audits, complaints, and appeals•Received commendation from accreditation body (ANSI) for the quality system

Detroit, Michigan

Conducted domestic inspections and import investigations/operations of FDA regulated establishments:o Conducted interviews, gathered information, samples, and evidence o Wrote establishment inspection reports (EIRs), issued FDA 483s, worked with Centers, and conducted follow-up inspections to ensure resolution of violations cited • Identified FDA import provisions per the FD&C Act to make necessary administrative decisions during import entry review which included: may proceed notices, detention notices, sampling notices, and notices of further compliance action• Worked with vendors, U.S. Customs, U.S.D.A., brokers, and consignees solve local import issues• Designed and delivered a 3-day training course for all FDA Detroit District personnel on conducting and documenting investigations and import operations. Developed course training materials, interactive PowerPoint presentations, daily quizzes, breakout sessions, and metrics for evaluating the course

Certificate, Executive Leadership

Certificate, Biomanufacturing

Certificate, Dacum Training Program

DACUM (Developing a Curriculum) occupational analysis process

Certificate, Test Design And Delivery

Certificate, Instructional Design

Certificate, Instructional Design

D.P.M., Podiatric Medicine/Podiatry

Interdisciplinary/Pathology

Conducted research in liver regeneration and attended Ph.D. classes

Master Of Science - Ms- Biology

Activities and Societies: Courses and researchTeaching Assistant Conducted bench research Completed courses towards Master's Degree.

Bachelor'S Degree, Biology

Activities and Societies: Played Division 1 Tennis