IT Compliance for Regulated Industries

I have successfully established comprehensive QA standards for EDC platforms serving global pharmaceutical clients, maintaining a 100% compliance record while leading customer audits and implementing quarterly release management processes. My deep understanding of regulatory frameworks including FDA CFR 21 Part 11, HIPAA, GDPR, and ISO standards has enabled me to drive critical compliance initiatives that protect organizations from regulatory risk while supporting business objectives.
Throughout my career, I have consistently delivered results across organizations ranging from innovative start-ups to industry-leading global enterprises. At Alcon, I successfully managed global application migrations during the Novartis transition, developing new project management methodologies and leading Zero Paper Process validations in Agile environments. My diverse experience spans from early-stage biotechnology companies like Aduro Biotech to pharmaceutical giants like Novartis and Gilead Sciences, giving me unique insight into the compliance challenges and operational needs across the full spectrum of company sizes and maturity levels. This breadth of experience has strengthened my ability to navigate diverse technical landscapes while ensuring regulatory compliance and quality standards are never compromised, regardless of organizational scale.
What sets me apart is my unique combination of technical expertise and strategic leadership capabilities. I hold both a Master's degree in Operations and Project Management and active PMP certification, complemented by hands-on experience with emerging technologies including AI governance frameworks. My ability to collaborate effectively across Development, Product Management, Operations, and Support teams has been instrumental in driving process improvements and standardization initiatives that deliver measurable business value.
Key qualifications I bring includes:
• Regulatory Expertise: Deep knowledge of 21 CFR Part 11, ISO 9001/27001/42001, Annex 11, HIPAA, and GDPR compliance requirements
• Project Management Excellence: Proven track record managing 20+ concurrent projects using Agile, Waterfall, and risk-based methodologies
• Quality Leadership: Extensive experience implementing QMS systems, conducting audits, and managing Computer Systems Validation (CSV) processes
• Cross-Industry Experience: Success across pharmaceutical, biotech, clinical, and medical device sectors
• Technical Innovation: Current expertise in SaaS compliance, cloud computing, and AI governance frameworks

Work Terms

Open to any hours, payment terms, and communication styles.