Daniel Velez-Casiano

Senior Manager - IT & Quality Systems | GxP / CSV | Digital Quality & QA Compliance Leader
  • Just - Evotec Biologics

Global operations leader with over 25 years of experience overseeing large-scale validation, quality, and compliance initiatives for top biotechnology and pharmaceutical organizations in the U.S., Europe, and Latin America. Expert in steering multimillion-dollar projects across manufacturing, R&D, and IT, integrating technology, quality, and regulatory strategies that strengthen business continuity, operational resilience, and product integrity. Recognized for transforming departments into data-driven, value-adding functions and leading multidisciplinary teams through complex modernization, remediation, and GMP-readiness programs.

  • Global Systems Compliance – Computerized System Validation (CSV) – GxP & Data Integrity – Budget Control
  • Operational Excellence – Strategic Leadership – GMP Implementation – Project Governance – Business Continuity
  • Technology Integration – Automation & Controls –  External/Internal Audits – IS Business Systems
  • NCR Investigations – Analytical Methods — Change Control – Cross-Functional Teams Oversight

Strategic Leadership & Oversight: Directed global IT compliance, validation, and system governance for multiple international sites, managing cross-continental teams of 15+ and multimillion-dollar budgets while advancing organizational integration and digital transformation.

Global Quality Governance: Spearheaded end-to-end validation of over 30 GxP systems and enterprise platforms (MES, SAP, Maximo, PI, PCS, BMS), ensuring compliance with FDA, EMA, and MHRA regulations. Standardized global processes for disaster recovery, change control, and project management.

Regulatory & GMP Compliance: Supported facility startups and readiness programs for GMP certification, audits, and regulatory inspections with zero critical findings, aligning system validation and documentation with 21 CFR Part 11, Annex 11, and ICH guidelines.

Operational Transformation & Talent Development: Elevated the visibility and strategic impact of information systems through the establishment of governance committees, data-driven business cases, and succession planning programs, resulting in $200K annual savings and enhanced team engagement.