David S.

About David S.

Results driven, twenty-five (25) year Validation/Quality/Compliance professional with leadership/consulting and advising experience that include the development and maintenance of the quality management systems and the governing process for the entire lifecycle of equipment, utilities, processes, facility, and software. This includes computer system validation, laboratory management, clinical process management, data migration, quality issue and deviation handling, change and incident management and CAPA management and lead internal and vendor audits. Create, modify, and enforce the quality management system for companies to adhere to the compliance of pertinent pharmaceutical/medical device/clinical standards and regulations. Identify, facilitate, and lead project teams in the implementation of IT improvement initiatives and projects in accordance with GxP (cGMP, GCP, GLP, GVP), ICH and Sarbanes-Oxley expectations to improve compliance, quality levels and improve operational efficiencies. Strategically manage the implementation of large-scale enterprise platforms/solutions per GxP guidelines and regulations and company system development lifecycle. Manage and support project activity among project team members to ensure coordinated and timely completion of project deliverables. Expert in 21 CFR Part 11, Annex 11 and all international equivalent regulations. A subject matter expert in providing leadership and compliance input on GxP (regulatory) related quality and IT projects, assessing user and functional requirements, validation scope and developing training materials. Develop and deliver quality functional goals aligned with corporate strategy and operations, quality risk assessment and mitigation. Provide operational and professional leadership and responsible for quality oversight of all GxP activities. Provide strategic insight to annual, long-range planning and budgetary processes. Experienced in all phases of drug development from clinical through to commercial drug product. Expert in the system development life cycle methodology including developing, writing, reviewing, and maintaining system documents and standard operating procedures, validation deliverables including specification documents (design/configuration, user/business and functional), IT test management (Validation Test Scripts), reports, incident/change controls (Incident/Problem and Change Management) and certification summaries.

Experience

1. Program Manager

   Verily Health

   Oct 2023 — Present · Raleigh, NC, US

Education

• University of North Carolina at Chapel Hill

  Bachelor of Science - BS