Solution Architect

About the role:

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 ...