Operational Compliance Associate (M/W/X)

Amaris Consulting; Gent; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is seeking an Operational Compliance Associate to ensure GxP compliance of operational industrial IT assets at client sites. The role involves daily follow-up, troubleshooting, monitoring, and maintenance of OT systems, interacting with end-users and IT teams to uphold regulatory standards.

Applicants should have experience with regulated environments, GMP/GDP knowledge, and familiarity with SAP and ticketing systems.

Qualifications

• Experience in a regulated (GxP) environment applying GMP/GLP/GDP principles.
• Knowledge of GAMP 5 guidelines for computerized systems.
• Familiarity with IT and OT systems in pharma/biotech settings.

Responsabilités

• Plan, monitor, and maintain operational industrial IT assets.
• Manage user access for OT systems.
• Follow up incidents and support resolution.
• Support investigations, deviations, and root cause analyses.
• Track CAPAs and ensure timely closure.
• Document audit trails and validation activities.
• Schedule recurring OT maintenance tasks.
• Update SOPs, WIs, and forms.
• Ensure GxP compliance and data integrity.
• Collaborate with engineers and stakeholders.

Connaissances

GxP compliance

Regulatory knowledge

OT/ICS

Documentation

SAP

Ticketing systems

Change management

ISA-88/95

Data integrity

NIS2

Formation

Bachelor or Master in IT/Engineering

Outils

SAP

SharePoint

Validation tools

Ticketing

Description du poste

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 reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together.
• Health insurance, remote work, meal vouchers, time savings account, referral bonus…

Mantu is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

Brief Call

Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews

(the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study

Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!