Operational Compliance Associate (M/W/X) (GxP/Industrial IT)

Location: Ghent, Belgium

Company

hirify.global is an independent technology consulting firm providing IT, telecom, life sciences, and engineering solutions to businesses through international client projects.

What you will do

• Plan, monitor, troubleshoot, and maintain operational industrial IT assets in regulated client environments.
• Manage OT user access, incidents, service resolution, deviations, investigations, root cause analyses, and CAPAs.
• Perform and document audit trail reviews and recurring maintenance activities, including patching and upgrades.
• Manage application changes, including impact and risk assessments, and prepare Change Control Board materials and reports.
• Prepare and execute CSV validation activities, protocols, and test scripts in line with GAMP 5.
• Maintain SOPs, work instructions, forms, reports, and standardized operational industrial IT processes in accordance with GDocP and cGMP requirements.

Requirements

• Experience with operational industrial IT systems in a regulated GxP environment.
• In-depth knowledge of GMP standards and related guidance, including 21 CFR Part 11, EU GMP Annex 11, Data Integrity, ISA-88, ISA-95, ICH, FDA, FAGG/FAMHP, and ISPE guidance.
• In-depth knowledge of GAMP 5 for computerized systems.
• Bachelor’s or Master’s degree in Engineering, IT, Science, or a related discipline.
• Fluent English, strong organizational and scheduling skills, a hands-on approach, attention to detail, and the ability to coordinate work independently.
• Proficiency in Microsoft Office and SharePoint.

Nice to have

• Knowledge of cybersecurity principles and NIS2 requirements.
• Experience with industrial automation technology and pharmaceutical validation standards.
• Experience with SAP, ticketing systems, quality event management systems, document management systems, or change management systems.
• Dutch language skills.

Culture & Benefits

• Long-term projects averaging more than 18 months with major accounts and support from internal Centers of Excellence.
• Structured project check-ins, dedicated management support, and regular access to HR.
• Functional and geographic mobility across multiple areas of expertise and more than 60 countries.
• Access to training modules, fully funded Microsoft certifications, and internally developed AI tools.
• Health insurance, remote work, meal vouchers, a time savings account, and a referral bonus.

Hiring process

• Brief virtual or phone conversation.
• Approximately three interviews with the line manager and relevant stakeholders.
• Role-dependent case study, technical assessment, role play, or problem-solving exercise.