David Dabbs

QMM Assessor/SME

David Dabbs is a distinguished Quality Assurance and Operations leader with over two decades of experience in the pharmaceutical, medical device, and biologics industries. He has consistently demonstrated his expertise in managing quality systems, ensuring regulatory compliance, overseeing supplier quality, and directing multi-site operations, all while driving continuous improvement and
strategic initiatives.

Mr. Dabbs possesses extensive expertise in Quality Assurance, with a proven track record in quality systems management, regulatory compliance, audits, CAPA management, and risk assessments across the pharmaceutical and biologics sectors. His technical and regulatory proficiency is evident through his adeptness with multiple eQMS platforms, including TrackWise and Veeva, and his comprehensive
knowledge of GMP, GCP, ISO, and FDA regulations.

His experience in supplier quality and change control is extensive, having held senior roles managing supplier onboarding, audits, change control processes, and CAPA at companies such as Fujifilm Dyosynth, Mural Oncology, and Regenxbio. Additionally, Mr. Dabbs has demonstrated his proficiency in technical writing and documentation by authoring and revising numerous SOPs on materials management, change control, and quality policies for companies including eGenesisBio and Axcella Therapeutics.

In the realm of medical device and biologics quality management, Mr. Dabbs has directed QA/QC teams, managed environmental monitoring, adverse event reporting, and regulatory compliance at firms such as Quality BioResources and BPL. His project and operations management skills are evident through his oversight of multi-site operations, quality manufacturing, calibration, and training programs, with roles
at Janssen, Pharmedium, and GSK.

Mr. Dabbs is committed to continuous improvement, consistently leading gap assessments, risk management, and remediation efforts to enhance quality systems and regulatory compliance.