IT Applications Director

Introduction to Ardena

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 700 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

Our culture is built on openness, transparency, and ownership. We value collaboration, trust, and initiative, and we believe that strong teamwork and an open mindset are essential to delivering high-quality solutions in a highly regulated and fast-moving industry.

If you are motivated by meaningful work, enjoy collaborating with experts, and want to contribute to the development of medicines for unmet medical needs, Ardena offers an environment where you can truly make an impact.

To strengthen our Corporate IT leadership team, we are looking for a seasoned

IT Applications Director

In this role, you will report directly to the Chief Information Officer and take ownership of Ardena’s full application portfolio: spanning quality, manufacturing, laboratory, commercial, and corporate systems. You will work closely with business unit leaders, system owners, and IT teams across our international sites to ensure applications deliver maximum value, remain fully compliant with regulatory requirements, and support Ardena’s continued growth.

This is a strategic and hands-on leadership role that combines technical depth with strong business partnership to drive application excellence across a multi-site, GxP-regulated environment.

YOUR KEY RESPONSIBILITIES

Application Portfolio & Strategy

• Own and evolve Ardena’s application portfolio strategy, covering ERP, LIMS, QMS, MES, CRM, and other business-critical platforms.
• Partner with business unit leaders to understand evolving needs and translate them into application roadmaps and investment plans.
• Drive standardisation and harmonisation of applications across sites, reducing complexity while improving user experience.
• Lead evaluation, delivery and adoption of application platforms aligned with Ardena’s digital transformation objectives.

Delivery & Lifecycle Management

• Lead the selection, implementation, and lifecycle management of enterprise applications, from requirements gathering through go-live and continuous improvement.
• Oversee application upgrades, migrations, and decommissioning programmes, ensuring minimal business disruption.
• Define and maintain application architecture principles, integration standards, and data governance practices.
• Collaborate with IT Infrastructure, IT Security, and the AI team to ensure a secure, scalable, and well-integrated application landscape.

Compliance & Governance

• Ensure all applications comply with GxP requirements (21 CFR Part 11, Annex 11), GDPR, ISO 27001, and relevant information security standards, Ardena’s IT governance policies.
• Maintain thorough system validation documentation and support audit and inspection readiness.
• Manage change control, risk assessments, and periodic reviews for validated systems in line with regulatory expectations.
• Define and oversee testing strategies for validated systems, including IQ/OQ/PQ protocols, UAT, and regression testing, applying a risk-based approach in line with GAMP 5 principles.

Team & Vendor Management

• Lead and develop a team of application managers, business analysts, and support specialists across sites.
• Manage vendor relationships, contracts, and SLAs for application services and software licences.
• Manage the IT Applications budget, ensuring optimal return on investment and alignment with business