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.
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.
- 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.
- 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.
- 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 priorities.
- Contribute to the broader IT strategy and represent IT Applications in leadership forums.
- 10+ years of experience in IT, with at least 5 years in an application management or IT leadership role.
- Proven experience delivering enterprise application programmes in a life science, pharmaceutical, or comparably regulated environment (GxP, 21 CFR Part 11, Annex 11).
- Familiarity with information security standards and frameworks, including ISO 27001 (ISMS); experience operating in an ISO 27001‑certified or equivalent environment is a plus.
- Solid experience with system validation and testing methodologies, including IQ/OQ/PQ, UAT, and regression testing; knowledge of GAMP 5 risk‑based approaches is strongly preferred.
- Strong knowledge of ERP systems (preferably Microsoft Dynamics Business Central), LIMS, QMS, and/or MES platforms.
- Track record of delivering complex application implementations and modernisation programmes on time and within budget.
- Solid understanding of application architecture, integration patterns (API, middleware), and data management principles.
- Experience with cloud platforms (Microsoft Azure, AWS, or equivalent) and SaaS application management.
- Demonstrated people leadership skills, with a track record of building and developing high‑performing, cross‑functional teams.
- Excellent stakeholder management and communication skills — able to bridge technical and business perspectives at all levels.
- Familiarity with ITIL service management practices.
- Experience in a CDMO or contract services environment is a strong plus.
- Fluency in English; proficiency in Dutch, German, or Spanish is an advantage.
- Willing and able to travel to several locations to support and work with the local teams (Travel 25% of the time.)
- A challenging and impactful leadership role in a learning organisation that supports professional growth.
- A collaborative, international working environment with engaged and knowledgeable colleagues.
- An open corporate culture with short communication lines.
- Attractive employment conditions.
- Flexible working hours to support work–life balance.
€90000 - €120000 monthly