At Foundation Medicine, I restructured clinical CAPA workflows in Veeva eQMS, closing critical data-collection gaps and improving corrective-action tracking. I also turn FDA regulations and cGMP-adjacent guidance into practical SOPs, job aids, and training.
I've managed QA casework, deviation investigations, root-cause analysis, supplier qualification, material disposition, and inspection readiness across FDA and CAP audit environments. My dashboards in Tableau and Confluence give leadership clear visibility into quality metrics and non-conformance trends.
Previously at Kryosphere and Tempus AI, I supported global clinical-trial kitting, investigational product release, biospecimen operations, laboratory validation, and NGS quality-control programs. I have led internal audits, supplier audits, incoming-material release workflows, and environmental monitoring responses.
My laboratory foundation comes from Duke University Hospital, where I led internal audits, supported clinical trials, validated databases and testing pathways, and managed transfusion logistics. I bring a practical, systems-focused approach to protecting data integrity and regulatory compliance.
