Kim Moore

Led regulatory inspection and sponsor audit readiness efforts, coordinating responses and managing CAPA remediation to ensure timely corrective action closure. Directed supplier qualification, risk assessments, and GxP/QMS/CSV-SDLC audit activities, including governance of Quality Agreements and MSAs aligned to 21 CFR Part 11, FDA, and GxP requirements.

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.

Owned global QMS operations across document control, CAPA, and internal audit programs while supporting sponsor and compliance improvements. Led CSV documentation and system lifecycle compliance, executed risk-based vendor RFP evaluations, and partnered with Legal and Procurement to ensure QA/GxP requirements were contractually embedded in MSAs.

Spearheaded enterprise QMS operations by embedding quality requirements into SDLCs and product release cycles and executing risk-based internal audits with stakeholder-ready findings. Directed enterprise GxP training programs, including training assignment tracking, overdue follow-up, compliance reporting, and ongoing curriculum updates based on SOP revisions and audit/CAPA outcomes.

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.

Managed qualification protocols for commissioning and IQ/OQ/PQ activities, covering new software, equipment, and data integrity requirements. Performed risk assessments for new systems and led system retirement planning to support secure decommissioning.

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 quality and compliance programs supporting pharmacovigilance operations and led regulatory training for globally distributed teams. Eliminated 100+ overdue CAPAs through risk-based prioritization and remediation, while driving internal audits, client audits, and regulatory inspections to achieve zero critical findings.

Directed corporate CAPA governance reviews aligned to operational goals and objectives, and led quality assurance training while acting as a CAPA subject matter expert. Hosted NRC inspections and achieved zero critical findings.

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.