Solution Architect

hace 2 días

Barcelona, Barcelona, España Fresenius Kabi USA A tiempo completo
About the role:

The Solution Architect (m/f/d) – Regulatory & Compliance Applications is responsible for the operation, optimization, and continuous evolution of global regulatory IT solutions. The role ensures full alignment with Good Practice (GxP) requirements, regulatory authority expectations (U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council for Harmonisation (ICH)), and business objectives, while driving operational excellence, data integrity, and system reliability across the regulatory application landscape. 

Your key responsibilities:
  • Serve as the main technical and functional point of contact for regulatory business process owners, providing governance, consultation, and solution direction. 
  • Design, configure, monitor, and maintain regulatory IT solutions in compliance with global regulatory standards (FDA, EMA, ICH, GxP).
  • Lead and support the full application lifecycle, including upgrades, migrations, integrations, and decommissioning activities.
  • Prepare detailed project proposals (scope, timelines, effort, cost estimates) in close collaboration with Demand Owners and stakeholders. Coordinate and document system operations, releases, validation activities, and change management processes.
  • Oversee incident, problem, change, and release management, including vendor coordination and escalation management.
  • Support internal and external audits and regulatory inspections related to RIM and submission systems.
  • Actively manage stakeholder communication and alignment across Global IT, QA, Regulatory Affairs, and external vendors.
Your skills and experiences:
  • Academic degree in IT, Business, Life Sciences, or a related field, or equivalent professional experience in regulated pharmaceutical environments. 
  • Multi-year experience in application lifecycle management of IT solutions within a GxP-regulated environment. 
  • Proven hands-on experience with Regulatory Information Management and submission systems.
  • Experience in leading and contributing to global IT projects with cross-functional and international stakeholders.
  • Excellent communication skills across cultures and organizational levels, with the ability to translate business needs into technical solutions. 
  • Strong collaboration skills, with the ability to build trust and work effectively in a global, virtual environment.
  • Proven hands-on experience with the following solutions would be considered an advantage but is not mandatory (e.g. OpenText Documentum LSS, Generis CARA5, Extedo eCTDmanager, Lorenz eValidator and Veeva RIM).
Why join us?

At Fresenius Kabi, you'll contribute to something meaningful: delivering life-saving therapies to patients around the world. As a Solution Architect Regulatory & Compliance Applications and a part of a global transformation, you will actively shape the future of our global regulatory system landscape and ensure that our digital solutions meet the highest standards of quality, compliance, and operational excellence. 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.

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