GxP Compliance & Validation Planning Consultant (SAP)

TL;DR

GxP Compliance & Validation Planning Consultant (SAP): Leading validation planning and GxP compliance strategy for large-scale SAP S/4HANA transformation programs with an accent on regulatory alignment and quality governance. Focus on coordinating cross-functional stakeholders, overseeing validation documentation, and ensuring inspection readiness within regulated environments.

Location: Must be based in Budapest (Hybrid)

Company

hirify.global is an independent IT consulting and services company founded in 1999, providing innovative solutions for financial, telecommunications, automotive, and energy sectors.

What you will do

• Develop and maintain the overall GxP and validation strategy for SAP S/4HANA programs.
• Coordinate validation planning activities across various workstreams and deployment phases.
• Ensure alignment with GAMP 5, CSV/CSA methodologies, and data integrity principles.
• Advise program leadership on compliance impacts and regulatory considerations.
• Review validation-related plans and documentation prepared by implementation teams.
• Facilitate collaboration between Quality Assurance, IT, and business stakeholders.

Requirements

• 7+ years of experience in GxP-regulated environments.
• Strong experience with SAP ERP or SAP S/4HANA transformation programs.
• Solid understanding of GAMP 5, CSV/CSA, FDA 21 CFR Part 11, and EU Annex 11.
• Proven ability to coordinate cross-functional stakeholders in complex programs.
• Familiarity with validation lifecycle documentation and governance processes.

Nice to have

• Experience in pharmaceutical, biotechnology, or medical device industries.
• Background in regulated supply chain, manufacturing, or laboratory processes.
• Prior experience working alongside System Integrators on ERP implementations.

Culture & Benefits

• Transparent and open-door company culture.
• Focus on continuous learning and professional development.
• Stable background with exposure to the latest technologies.
• Emphasis on team spirit and collaborative project environments.