David Smith

Background

About David Smith

A personable Quality Assurance professional, ASQ Certified Quality Improvement Associate (CQIA), and GLP archivist with strong document management and training program management experience, with a proven record of quickly assimilating and mastering new skills and programs in CRO and pharmaceutical QA environments. Document management and maintenance of sensitive records through document control concepts, chain of custody control, knowledge of quality assurance requirements and regulatory policies in pharmaceutical and clinical research. Extensive knowledge in maintenance and control of GLP and clinical CRO SOP document repositories for both hard and soft documentation media, cataloging, storage, and management of retention/disposition schedules. Strong organizational and analytical skills demonstrated in ownership of the Veeva Vault as Business Administrator for Veeva QualitySuite (QualityDocs, Training and QMS), as the sole Document Control role for over 100 corporate SOPs, Work Practices and Policies. Project management skills demonstrated by meeting stringent response timelines, adhering to, but often exceeding client expectations and corporate standards in conduct of external audits by sponsors, partners or regulatory authorities, and management of audit responses and deliverables schedules. Quality Management soft skills include conducting new hire training, management and implementation of continuous improvement initiatives and creation and maintenance of related metrics capture, focusing on solutions, people and processes.