eCompliance & Validation Leader · Global Patient Safety Systems
GxP / GVP · FDA Inspection Readiness · AI Governance
Helping regulated organizations adopt AI safely — without slowing down.
CSV/CSA for GxP-regulated Patient Safety systems — Argus Safety, RxLogix, IVP Intake & Collect, TalkDesk, aMIR, Salesforce, and Artemis. Change control, SOP authoring, and end-to-end validation lifecycle management in PV-regulated environments.
Consent decree remediation, inspection preparation, audit management, and CAPA closure across pharma, biotech, and medical device organizations. Consistent zero critical findings track record across FDA inspections, Internal Audits, and regulatory reviews.
Responsible AI governance frameworks and AI-powered validation automation within GxP-regulated environments. Bridging the gap between AI adoption speed and compliance rigor — enabling organizations to move fast without putting patients or audits at risk.
FSV & MSIT Lead for Blood Collection, Testing & Distribution ERP validation. Helped ARC exit 14+ years of FDA oversight in 2 years, leading a team of 25 validation SMEs across 3 national site events.
Co-led enterprise-wide CSA transformation across 230+ GxP applications (BMS, Celgene, Juno) over 15 months. Weekly governance reporting to senior directors; monthly C-suite updates. Pioneered AI-assisted CSV documentation — ITVS Science Fair 2nd place.
Represented QSS function alongside the IT Director in an FDA inspection. Achieved zero critical findings. Also led a full QMS rebuild — SOPs, templates, Master Inventory — from the ground up.
Independent Quality Lead on McNeil/J&J Consumer FDA consent decree remediation (Tylenol-related FDA 483). Delivered GOLD project SAP go-live across 3 phases with zero critical compliance issues.
"REMS: Safeguarding Patients and Offering Strategic Opportunity." One of the earliest peer-reviewed analyses positioning REMS as both a patient safety compliance framework and a strategic business opportunity.
I work with pharma, biotech, medical device, and CRO organizations to validate and govern complex regulated systems — so they can move fast without putting patients or audits at risk.