Solution Architect - Regulatory & Compliance Applications

In this role you will be responsible for developing and maintaining Regulatory IT systems that align with GxP standards and business objectives, ensuring compliance, operational excellence, and seamless integration.

Your key responsibilities:

• Serve as the main technical contact, provide governance, and consult with process owners.
• Prepare detailed project proposals, including timelines, effort, and cost estimates in coordination with the Demand Owner.
• Configure, monitor, and maintain regulatory IT systems according to global standards (FDA, EMA, ICH).
• Coordinate and document system operations, migrations and releases.
• Oversee incident, problem, change, and release management, including escalation and vendor management.
• Ensure data integrity and compliance through testing and validation.
• Support audits and regulatory inspections.
• Deliver system admin training and maintain GxP compliance documentation.
• Integrate cybersecurity and data privacy requirements into solution designs.
• Manage stakeholder communication and coordinate with Digital Technology, QA, and business stakeholders.

Do you have experience in IT?, * Academic qualifications in IT, business, or related fields - or equivalent professional experience demonstrating technical and operational excellence, focusing on pharmaceutical area.

• Extensive multi-annual experience in application lifecycle management for IT- solutions in GxP environment
• Participation in and leading IT projects across global environments
• Strong communication skills across cultures and organizational levels, with the ability to align diverse stakeholders.
• Ability to build trust, foster strong working relationships, and collaborate effectively across global functions and with external partners in a virtual environment.
• Language & Mobility - Fluent English is required; additional languages are a plus. Willingness to travel internationally based on business needs.

At Fresenius Kabi, you'll contribute to something meaningful: delivering life-saving therapies to patients around the world. As part of a global transformation, you will work in a highly visible, impactful role with the opportunity to shape how we manage regulatory requirements and compliance. You will join a diverse and dynamic team in a collaborative environment where your expertise will help drive innovation, efficiency, and quality across our digital landscape. Auf einen Blick Frühestmöglicher Start: 01.02.2026 Beschäftigungsart: Unbefristet Unternehmen: Fresenius Kabi Standort: Barcelona, ESP Arbeitszeit: Vollzeit Einsatzbereich: Allgemeine IT