(Manager) Solution Architect (mfd) – Regulatory & Compliance Applications (RCA)
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Job Location:
Monthly Salary:
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
About the role:
The Solution Architect (m/f/d) Regulatory & Compliance Applicationsis responsible forthe operation optimization and continuous evolution of globalregulatory ITsolutions. The role ensures full alignment withGood Practice (GxP)requirements regulatory authority expectations (U.S. Food and Drug Administration (FDA) European Medicines Agency (EMA) International Council for Harmonisation (ICH)) and businessobjectives 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 configuremonitor andmaintainregulatory IT solutions in compliance with global regulatory standards (FDA EMA ICHGxP).
- 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 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 aGxP-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 ( Documentum LSS Generis CARA5ExtedoeCTDmanagerLorenzeValidatorandVeeva RIM).
Why join us
At Fresenius Kabi youll 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.
Required Experience:
Manager
Key Skills
- Business Process
- VMware
- Cloud
- HTML5
- Windows
- Project managements
- AWS
- Infrastructure
- Web Services
- JQuery
- Java
- Computer Engineering
- Solutions design
- Technical Solutions
- Analytics
About Company
A global player in the world of healthcare: Fresenius Kabi! ▶ Learn more about our different expertise fields ✓ responsibilites ✓ career opportunities ✓
