Regulated Product Operations & Enterprise Delivery Leader

MIKE CASTILLO

Product Operations Leader Enterprise / Regulated Systems

**************@*****.*** • linkedin.com/in/mikecastillo1

SUMMARY

Product operations and enterprise delivery leader with experience building and scaling product, delivery, compliance, and operational systems in complex regulated environments. Proven track record leading cross-functional modernization initiatives spanning product operations, SDLC governance, enterprise delivery, audit readiness, AI-enabled operational transformation, and customer-facing enterprise platforms.

EXPERIENCE

Director of Product Management / Regulatory Technology Lead Metrum Research Group 2024 – Present

●Drove ~57% revenue growth for a multi-million-dollar regulated enterprise platform, expanding enterprise clients 83% and increasing user adoption 43% by building and scaling the product, delivery, and commercial operating system

●Built and institutionalized enterprise operating systems spanning SDLC governance, PMO processes, release management, audit readiness, and global support operations

●Architected dual delivery frameworks for interconnected regulated systems, enabling parallel delivery without compliance risk while improving release throughput and delivery predictability

●Established 24/7 global support operations, expanding coverage from 8 to 24 hours and reducing SLA response times from 16 hours to 2 hours while implementing AI-assisted support tooling that improved customer satisfaction and operational efficiency

●Led audit defense and regulatory alignment initiatives across GxP-regulated environments, achieving zero audit findings while strengthening validation, traceability, and delivery controls

●Delivered a GxP-validated pathway giving pharma enterprise customers faster access to commercial AI tools (MATLAB Copilot, AWS Bedrock, GitHub Copilot, Posit AI) that are otherwise difficult to adopt in regulated environments, alleviating validation burden without compromising compliance; aligned to ISO/IEC 42001 AI management system guidance through a formal AI System Impact Assessment (AISIA)

●Built, trained, and led cross-functional product and delivery teams including TPMs, BAs, SQA, PMs, and Product Owners through translating business, operational, compliance, and technical requirements into prioritized roadmap initiatives and executable delivery plans

●Partnered closely with security leadership and enterprise stakeholders to operationalize security initiatives within SDLC governance, delivery processes, and roadmap planning

●Led platform modernization initiatives applying NIST Risk Management Framework and GAMP 5-aligned governance controls across operational, security, and AI-enabled workstreams, improving operational visibility, workflow efficiency, and delivery scalability

Product Manager Metrum Research Group 2020 – 2024

●Owned roadmap and delivery execution for a regulated enterprise platform, increasing delivery capacity from ~8 to 30+ projects annually while maintaining on-time, in-scope execution

●Coordinated cross-functional delivery across engineering, QA, operations, and customer stakeholders within regulated SDLC environments

Project Manager (Product-Focused Technology Solutions) Metrum Research Group 2020 – 2022

●Built and transformed delivery systems and release processes, replacing ad hoc upgrades with structured quarterly and biannual releases while improving delivery control and system reliability

●Led UAT, risk assessment, stakeholder communication, and release coordination supporting consistent audit success in regulated environments

Program Lead – State of Connecticut, Dept of Labor 2010 – 2020

●Led statewide technology and program initiatives for the CTHires platform, implementing Agile-based delivery processes, governance frameworks, and user-driven UAT feedback loops supporting successful statewide deployment

●Built stakeholder-aligned program roadmaps across state, federal, and external partners while implementing KPI-driven reporting supporting ongoing funding and operational performance

●Developed fraud prevention, audit, and operational control programs generating approximately $2.7M in savings

●Streamlined operational workflows and reporting processes, increasing efficiency and supporting multi-agency initiatives

SKILLS & EXPERTISE

Product Operations • Product Ownership • Enterprise Delivery • SDLC Governance • PMO Operations • Agile Delivery • Roadmap Governance • Release Management • Cross-Functional Leadership • Operational Risk Management • Audit Readiness • UAT • Stakeholder Management • AI Product Operations • Responsible AI • AI Impact Assessments • AI Risk Management • ISO/IEC 42001 • ISO 23894 • EU AI Act • GAMP 5 • 21 CFR Part 11 • EU Annex 11 • Validation (IQ/OQ/PQ) • AWS • Atlassian • HubSpot • Kantata

CERTIFICATIONS

PMP PSPO II PSM I SAFe 6

●AI Governance & ISO 42001 Readiness for GRC, Audit, & Legal (Specialization) — British Standards Institution (BSI), Coursera, Aug 2026

●Product Management Design to Launch: Harvard Division of Continued Learning

●AI Governance: Saïd Business School, University of Oxford

●Building AI Strategy Certificate: International Information System Security Certification Consortium (ISC)

EDUCATION

●MBA – University of Connecticut

●BA & BS – Business Administration & Political Science, Eastern Connecticut State University

ADDITIONAL INFORMATION

●U.S. Army Veteran, Iraq War Deployment

●Previously held U.S. Secret Security Clearance

VOLUNTEER EXPERIENCE

●Secretary, Treasurer, Veterans Advocacy Center, 2015-2017

●Vice President, Secretary, Veteran's Agricultural Center of CT, 2014-2015

●Eastford Volunteer Fire Company

PROFESSIONAL ASSOCIATIONS

●Project Management Institute

●International Society of Pharmaceutical Engineers (ISPE)

●American Society for Quality

●Scaled Agile, Inc.

●Scrum.org

AWARDS

●CT Veterans' Affairs Commissioner's Award, CT Dept. Veterans' Affairs

●Order of the Spur Indoctrination, 3rd Armored Cavalry Division, United States Army

●Willis N Hawley Service & Leadership Award, University of Connecticut

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