San Diego, California, United States
With a robust career at the nexus of IT and Life Sciences, my experience includes: ✅Ensuring GxP compliance of clinical trial and drug safety systems across cloud-hosted solutions ✅Leading international validation teams ✅Management of software nonconformances (CAPAs and Deviations) ✅Process management/process improvement ✅Supporting internal and sponsor prequalification audits Contact Info: ☎️ 415.577.7043 ✉️ [email protected]
⦁ Provide strategic guidance to life sciences organizations on GxP compliance frameworks, Computerized System Validation (CSV) / Computer Software Assurance (CSA) approaches, and regulatory requirements and industry guidance including 21 CFR Part 11, EU Annex 11, and GAMP 5 ⦁ Advise technology vendors on validation strategies and quality management system development to support audit and/or certification readiness and reduce client validation overhead ⦁ Contribute to the development of AI-powered compliance and validation solutions for the healthcare technology sector, applying regulatory expertise to emerging Digital Health Technologies ⦁ Support software implementation projects by defining validation requirements, risk-based testing strategies, and change management approaches for clinical trial and quality management systems
• Managed an international team responsible for validating clinical trial platforms while developing regulatory-compliant validation strategies. • Oversaw SDLC methods for CSV/CSA, maintained quality and compliance documentation, and implemented Risk Impact Assessments including GAMP 5 and Part 11 evaluations. • Supported internal and external sponsor audits. • Drove process improvements through KPI, CAPA, and root cause analysis while identifying and addressing gaps by creating SOPs and work instructions within the QMS. • Led comprehensive validation efforts for company platforms, including clinical research platforms and a software as a medical device (SaMD) platform. • Managed requirements gathering, validation documentation, and yearly Disaster Recovery exercises, including developing plans with defined RTO and RPO metrics and documenting results in DR Reports.
• Developed and maintained comprehensive QMS documentation and hosted both internal and customer audits while providing GxP and Part 11 training. • Managed documentation for NRG's AWS-hosted solutions, ensuring GxP compliance and data security. • Oversaw all product validation documentation supporting Waterfall and Agile methodologies, including risk assessments, requirements, test plans, and traceability matrices. • Led an international quality and validation team, handling project management and team performance.
• Created comprehensive software documentation for medical devices, including requirements, specifications, validation protocols and reports, while supervising protocol execution by lab staff. • Developed Quality System documentation and maintained an internal CAPA system. • Served as a key liaison between multiple departments including Quality, Software Development, Clinical, Regulatory, and Product Development for software projects.