With over 26 years of specialized experience in IT compliance across pharmaceutical, biotech, clinical, and medical device companies, I bring a unique combination of technical expertise and regulatory knowledge that directly addresses the complex challenges facing today's life sciences industry.
Currently serving as Director of Quality Assurance and Regulatory Affairs at ClinCapture, I have successfully led comprehensive regulatory compliance initiatives encompassing FDA 21 CFR Part 11, HIPAA, GDPR, ISO 9001, and ISO 27001 standards. My role involves overseeing the complete quality management system, conducting customer audits, managing quarterly software releases, and ensuring seamless integration of regulatory requirements with operational excellence. This experience has reinforced my ability to translate complex regulatory requirements into practical, implementable solutions that drive business success while maintaining the highest standards of compliance.
My educational foundation includes a Master's degree in Operations and Project Management (3.917 GPA) and extensive professional certifications, including PMP certification since 2006. This academic rigor, combined with hands-on experience managing multi-million dollar projects, positions me to deliver measurable results in challenging regulatory environments. At Pfizer, I successfully managed Part 11 remediation projects involving over 40 systems while maintaining budgets exceeding $500,000 under the allocated multi-million-dollar budget.
What sets me apart is my pragmatic, risk-based approach to regulatory compliance. Throughout my tenure at leading organizations including Alcon/Novartis, Gilead Sciences, Genzyme, and Baxter, I have consistently demonstrated the ability to navigate consent decree environments, implement comprehensive quality management systems, and lead cross-functional teams through complex validation processes. My expertise spans the full spectrum of regulatory requirements, from GxP compliance and computer system validation to data management and electronic records retention policies.
I am particularly drawn to opportunities where I can leverage my extensive experience in SaaS compliance, cloud computing, and Agile methodologies within regulated environments. My track record includes successfully transitioning organizations between different project management methodologies, developing innovative validation approaches for mobile medical applications, and establishing quality frameworks that support both compliance objectives and business growth.