Operational Compliance Associate

Job Description

Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization.

As an Operational Compliance Associate (M/W/X), you will play a central role in ensuring the GxP compliance of operational industrial IT assets at our client sites. You will be responsible for the daily follow-up, troubleshooting, monitoring, and maintenance of operational industrial IT systems, interacting with end-users, the IT department, and other stakeholders to ensure compliance within a regulated environment.

Your missions

• Plan, perform, and routinely follow up on operational industrial IT assets
• Manage, control, and monitor user access for OT systems
• Follow up on incidents and support service resolution
• Support investigations, deviations, and root cause analyses
• Track CAPAs to ensure compliance and timely closure
• Perform and document audit trail reviews
• Schedule and perform recurring routine OT maintenance tasks (patching, upgrades, etc.)
• Document actions taken and solutions implemented
• Identify improvement opportunities and drive efficiency enhancements
• Schedule, prepare, and document weekly, monthly, quarterly, and annual meetings and reports for operational industrial IT assets
• Prepare and report on team meetings and Change Control Board (CCB) meetings
• Manage changes for existing operational industrial IT applications, including impact and risk assessments
• Prepare and execute CSV validation activities, protocols, and test scripts in line with GAMP 5 requirements
• Update related SOPs, WIs, and forms for industrial IT assets
• Ensure compliance with cGMPs, global regulatory requirements, safety standards, SOPs/WIs, and corporate policies
• Uphold documentation standards and GDocP principles
• Support industrial IT engineers in writing and executing protocols and procedures
• Standardize general operational industrial IT processes and update related general SOPs/WIs/(e)Forms

Your profile

• Experience with operational industrial IT systems in a regulated (GxP) environment
• Proficiency in Microsoft Office and SharePoint
• In-depth knowledge of current GMP standards and related guidelines (21 CFR Part 11, EU GMP Annex 11, Data Integrity, ISA-88, ISA-95, ICH, FDA, FAGG/FAMHP, ISPE guidance)
• In-depth knowledge of GAMP 5 guidelines for computerized systems
• Knowledge of cybersecurity principles and NIS2 requirements is a plus
• Experience with industrial automation technology and validation standards relevant to the pharmaceutical industry is a plus
• Experience with SAP and ticketing systems is a plus
• Experience with quality event management systems, document management systems, and change management systems is a plus
• Academic background: Degree in Engineering, IT, Science, or related discipline (Bachelor or Master)
• English fluent. Dutch is a plus.
• You demonstrate strong organizational and scheduling skills, a hands-on mentality, and a great eye for detail. You work proactively, accurately, and in a structured manner, can independently plan and coordinate work, and communicate clearly and constructively with stakeholders. You are an open, collaborative team player with a strong service and problem-solving mindset, and you take ownership of assigned systems and tasks, ensuring timely follow-up and completion.

What We Offer

Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression.

In practical terms, here’s what this means for you on a daily basis:

• Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth.
• Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts.
• A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility is actively encouraged.
• Innovation, in practice 291 AI agents built in‑house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.
• CSR with real targets SBTi carbon