Kim Moore

Hosted regulatory inspections and sponsor audits, coordinating responses and CAPA remediation to close findings on time. Directed supplier qualification, risk assessments, and QMS/SDLC/CSV audits to meet 21 CFR Part 11, FDA, and GxP requirements, including end-to-end CAPA lifecycle ownership.

Led enterprise QMS activities including audit readiness, SOP/policy governance, and inspection support, achieving 100% on-time closure for regulatory and client audits. Served as QA SME for RFP evaluations and quality agreements/MSAs, created training curriculum with compliance oversight, and provided FDA/GxP regulatory advisement.

Owned global QMS operations across document control, CAPA, and audit programs, planning and executing internal audits and supporting sponsor and compliance improvements. Coordinated CSV documentation, led RFP evaluations, and drove quality agreement reviews to embed GxP responsibilities and risk controls.

Executed commissioning and qualification protocols (IQ/OQ/PQ) for new software, equipment, and data integrity requirements. Performed risk assessments for new systems and initiated decommissioning/retirement plans to support compliant transitions.

Directed QMS programs supporting pharmacovigilance operations and led global regulatory training to ensure seamless processes. Eliminated 100+ overdue CAPAs through risk-based prioritization and achieved zero critical findings by leading internal audits, client audits, and regulatory inspections.

Directed corporate CAPA governance reviews aligned to operational goals and delivered quality assurance training as a CAPA SME. Hosted NRC inspections with zero critical findings.

Supported ISO 27001 audit readiness initiatives through comprehensive gap assessments. Assessed alignment to NIST and FISMA to identify compliance gaps and readiness actions.

Grade: Honors

Earned an Associate of Science in Business Management (Honors) from DeVry University.