Sharp Logic Inc. is a boutique GxP advisory and quality systems consulting practice helping life sciences organizations lead AI adoption in CSV/CSA, transition from CSV to CSA, and navigate QMS platform migration.
Deep hands-on delivery experience across TrackWise and TrackWise Digital — implementations, migrations, and multi-site rollouts.
Backed by direct implementation experience — served as Project Sponsor and Leader for a VLMS rollout at a health tech client.
Deep experience guiding quality systems continuity and separation through mergers, acquisitions, and Transition Service Agreements.
Additional platform experience with Veeva Vault QMS and LabVantage LIMS, plus compliance and validation experience extending into CTMS, EDC, eTMF, and CDMS.
25+ years of GxP quality leadership across pharma, biotech, health tech, and CMO clients — including building quality infrastructure from the ground up for a health tech company and several other GxP organizations.
View LinkedIn profile →Life sciences executive and trusted advisor with 25+ years leading GxP quality systems, CSV/CSA, and digital transformation in regulated environments. Recognized for building enterprise-grade quality management systems from the ground up, pioneering AI and CSA adoption in GxP validation programs, and advising C-suite leadership on GxP governance, inspection readiness, and Pharma/Quality 4.0 strategy.
Deep practitioner expertise across GCP, GMP, and GLP — combined with executive program management credentials (MBA, MS, PMP, ISO Lead Auditor) — translates complex regulatory requirements into actionable business strategy. Track record delivering results across clinical-stage biotechs, global pharma, CMOs, and life sciences technology companies, including as VP & Head of Quality at Pi Health.