Paul Nepomuceno

About Paul Nepomuceno

Paul Nepomuceno is a seasoned Regulatory, Validation, and Quality Systems professional with over a decade of experience advancing compliance, innovation, and product integrity across the medical device, biotech, digital health, and defense sectors. He has led Computer Software Assurance (CSA) and Computer System Validation (CSV) programs for SaMD, SiMD, Class electromechanical devices, embedded firmware, and enterprise GxP systems, integrating FDA QSR and ISO 13485 design control principles with modern, risk-based validation approaches.At Nucleus Biologics, a leader in personalized cell-culture solutions, Paul spearheaded CSA-based validation of the electronic Batch Record (eBR) system—covering media buffers, formulation modules, and manufacturing workflows—using a GAMP 5 risk framework aligned to patient impact. He validated both Category 4 Configured Products (e.g, Oracle Cloud ERP, Teamcenter PLM, Veeva Vault QMS) configured to user needs, and Category 5 Custom Applications (e.g, AI/LLM-driven low-code tools built on Microsoft Power Platform, integrated with SAP and MES for GMP-compliant operations). He applied risk-based CSA principles—mapping intended use, process risk, and assurance method—to right-size evidence, eliminate redundant testing, and concentrate validation on critical-to-quality functions such as e-signatures, audit trails, and batch-release logic.Paul authored and executed URS, VMP, TM, IQ/OQ/PQ, and VSR deliverables for digital manufacturing and automation solutions, integrating Power Apps, Power Automate, Power BI, and Dataverse with SAP, Dynamics 365, LIMS, and SharePoint for traceable, audit-ready data flows. He also developed real-time Power BI dashboards to monitor material availability, lead-time risk, and formulation demand trends.He maintains expert command of 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, EU MDR, IEC 62304, and GAMP 5 (2nd Edition), having driven CSA/CSV validation across both non-product systems (ERP, PLM, QMS) and product software (SaMD/SiMD).Previously, Paul supported software validation and design controls for Medtronic’s Hugo™ RAS robotic surgery platform at Kontron, ensuring IEC 62304 compliance; advanced supplier quality and risk-based validation at Stryker; and, earlier, at BAE Systems, served as Project Engineer and Assessment Director for CANES (Consolidated Afloat Network and Enterprise Services), integrating computer systems validation and fiber-optic command infrastructure for combat systems.

Experience

1. Quality Management Systems - Regulatory Affairs - Design Controls - Specialist

   Hardy Process Solutions

   Feb 2026 — Present · San Diego, CA, US

   Paul Nepomuceno is a Quality Management leader at Hardy Process Solutions, driving enterprise-wide ISO 9001 system effectiveness and operational excellence. He is focused on transforming the Quality Management System from a compliance-based framework into a strategic business enabler that strengthens performance, reduces risk, and enhances customer confidence.He leads cross-functional initiatives that integrate quality with operational and financial performance. His work includes implementing and operationalizing Cost of Quality (CoQ/PONC) metrics to quantify business impact, aligning RMA–MRB–Inventory processes within IFS 10 to improve traceability and data integrity, strengthening the Design & Development framework through risk-based thinking, and advancing supplier performance through structured SCAR and root cause methodologies.Paul emphasizes measurable, data-driven systems that directly connect quality performance to financial outcomes and executive decision-making. He has elevated Management Review into a performance-focused leadership platform that supports strategic alignment and accountability across functions.Known for his systems-oriented approach, Paul integrates quality, operations, engineering, supply chain, and finance to build scalable processes that drive sustainable continuous improvement. His leadership positions quality management as a core contributor to operational excellence and long-term organizational performance.

Education

• Mondriaan Aura College

  Bachelor of Applied Science - BASc, Industrial and Organizational Psychology

Skills

• Headaches
• Healthcare
• Bodywork
• Captivating Video Content
• Building Digital Assets
• Wellness
• Project Management
• Back Pain
• Customer Service
• Niche Strategy
• Marketing
• Brand Strategy
• Electrical Engineering
• Laser
• Therapeutic Massage
• Alternative Medicine
• Nutrition
• Insomnia
• Microsoft Office
• Sales
• Structural Integration
• Sales Funnels
• Stress Management
• Microsoft Word
• Strategic Planning
• Product Development
• Acupuncture
• Injury
• Sports Injuries
• Moxibustion
• Fibromyalgia
• Social Media Marketing
• Microsoft Excel
• Email Marketing
• Video Marketing
• Qigong
• Migraine
• Team Building
• Management
• Tui Na