Senior IT Project Governance Specialist | CSV Consultant | GAMP® 5 Lifecycle Expert | IPMA® Level B

B2B Technological Governance and Senior Project Management asset with 20 years of robust experience directing mission-critical enterprise transformations across prime-tier telecom networks and multinational matrix organizations.

Specializing strictly in bridging the operational gap between high-scale enterprise software implementations (SAP, ERP, MES, Cloud) and strict European regulatory compliance standards within Life Sciences, BioTech, and Pharma matrices. Driven by a rigorous Risk-Based Approach (GAMP® 5 / EudraLex Annex 11) to eliminate operational chaos and deliver digital transformations in a guaranteed, audit-ready state.

CORE CERTIFICATIONS & METHODOLOGIES:

• IPMA® Level B Certified (Senior Project/Program Manager)

• ICH Good Clinical Practice (GCP) Certificate — E6(R3) Compliant

• ISO 13485:2016 Medical Devices — Quality & Audit Discipline

• ITIL® Framework Expertise (IT Service Management & Governance)

• Advanced Change Management & Stakeholder Alignment Methodologies

KEY DELIVERY FRAMEWORKS & EXPERTISE:

• Computer System Validation (CSV) & Lifecycle Engineering (GAMP® 5 Categories 1, 3, 4, 5)

• European Pharma Compliance Architecture (EudraLex Volume 4 Annex 11 & FDA 21 CFR Part 11)

• End-to-End Validation Verification (IQ / OQ / PQ Test Matrices & Documentation)

• Hardening Data Integrity Governance & System Infrastructure (ALCOA+ Core Principles)

TECHNICAL SKILLS & INDUSTRY TAGS:

Computer System Validation (CSV), GAMP 5, EudraLex Annex 11, FDA 21 CFR Part 11, IPMA Level B, ISO 13485, ICH GCP, ALCOA+, IQ/OQ/PQ, IT Governance, ITIL, Project Management Office (PMO), Cloud Qualification, Change Control, Vendor Management, SAP Validation, Deviation Management, CAPA, Audit Readiness.