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SAP Compliance Lead
vor 2 Monaten
About Fresenius Digital Technology
Fresenius Digital Technology is a leading provider of innovative IT services to the healthcare industry. As an internal IT service provider, we support all business units of the Fresenius Group with cutting-edge technology solutions.
Job Summary
We are seeking an experienced SAP Compliance Lead to join our team. The successful candidate will be responsible for managing the implementation of SAP S/4HANA, ensuring compliance with regulatory requirements, and leading a project team to deliver high-quality results.
Key Responsibilities
- Lead the setup of a qualified and validated SAP S/4HANA platform, enabling regulated customers to build compliant business processes.
- Manage a project team to ensure regulatory requirements, including supporting internal process owners in the re-design of SOPs, templates, and supporting processes.
- Manage the qualification of infrastructure and tools, ensuring the development and review of key project deliverables such as qualification plans, risk assessments, and technical specifications.
- Manage the validation of platform components, delivering and reviewing e.g. validation plans, test strategies, and traceability matrices.
- Support internal process owners in assessing and implementing regulatory requirements for new processes in future operational environments, ensuring compliance with regulations.
- Coordinate with internal and external stakeholders, including suppliers, to achieve a validated and qualified state, and manage escalations for compliance-related and disciplinary issues.
- Ensure quality assurance, compliance, and continuous improvement within projects, while managing resources and team performance in a complex, international environment.
- Provide input to departmental budgets, monitor allocated budgets, and represent the organization to cross-functional stakeholders, business partners, and external groups.
Requirements
- A degree in natural sciences, economics, or equivalent, combined with at least 10 years of experience in GxP computer system validation (and preferably qualification of IT infrastructure) as well as at least 5 years of experience in SAP transformation projects.
- Extensive knowledge with SAP in cloud installations as well as knowledge of SAP S/4HANA, BTP, ALM, and relevant regulatory frameworks (e.g. GxP, GAMP 5, SOX, ITIL).
- Proven experience in managing large teams as well as internal and external suppliers.
- Experience in the creation, maintenance, handling, and application of documents.
- Excellent conflict resolution, moderation, presentation, and communication skills in English, German would be an advantage.
- Highly experienced in strategic as well as project, quality, and risk management.
- Competence in compliance controls as well as data protection, IT security, and requirements engineering.
- A highly organized, customer, and solution-oriented individual with both a strong ability to navigate complex, constantly changing environments and a high level of confidentiality.