Functional Analyst (ISG) – Senior ELN/SDMS Consultant

About the role

We are seeking a Senior ELN/SDMS Consultant to act as a Functional Analyst (ISG) for a global life‑sciences client. The role is based in Zagreb and operates in a regulated GxP environment, supporting the NuGenesis SDMS platform and ensuring compliance with FDA and EU requirements.

Key responsibilities

• Validate NuGenesis SDMS against GxP, FDA 21 CFR Part 11 and EU Annex 11 standards.
• Configure and maintain file capture processes within the system.
• Provide L2/L3 technical support, incident handling and problem‑management for production issues.
• Assist with IQ, OQ and PQ validation protocols and related documentation.
• Support internal and external audits, inspections and regulatory reviews.
• Participate in system implementations, migrations and deployments.

Required profile

• Minimum 3 years hands‑on experience with NuGenesis SDMS.
• Background in life‑sciences or pharmaceutical environments.
• Strong understanding of GxP compliance and system validation processes.
• Proven ability to work in a remote, globally distributed team.
• Excellent attention to detail and ownership mindset.

Required skills

• NuGenesis SDMS
• GxP compliance
• FDA 21 CFR Part 11
• EU Annex 11
• System validation (IQ/OQ/PQ)

What we offer

• Senior‑level position in a high‑impact, regulated environment.
• Opportunity to work on critical scientific data systems with international exposure.
• Comprehensive wellbeing program, private medical coverage, life insurance and 22 days of annual leave.
• Access to professional development, trainings and certifications.