Senior Manager IT Compliance (mfd)

We are seeking an experienced IT Compliance Manager to oversee and ensure the integrity and compliance of our IT systems particularly in the areas of IT General Controls (ITGCs) for SAP and finance this role you will work closely with various teams including Corporate Audit and IT Risk Management to identify assess and mitigate IT-related compliance risks. Validation and IT Quality will be crucial stakeholders to ensure alignment of ITGC framework with GxP lifecycle management requirements of computerized systems. This role requires a thorough understanding of regulatory requirements and the ability to implement controls that safeguard both the organization and its systems from compliance risks.

Key Responsibilities

IT General Controls (ITGCs) for SAP and non-SAP finance-related Systems

• Support in the design implementation and monitoring of IT general controls for SAP and non-SAP finance-related systems to ensure adherence to internal and external compliance standards.

• Ensure that all controls for financial data processing reporting and access are functioning effectively and in line with relevant regulations and collaborate with the finance team to ensure alignment between financial reporting and ITGCs.

IT General Controls for GxP Systems

• Oversee IT general controls for GxP-regulated systems to maintain compliance with applicable regulatory standards (e.g. FDA GMP GxP guidelines) and partner with stakeholders in IT and Internal Control departments to define synergies in ITGCs definition for all systems including GxP.

• Evaluate SOC reports of partners providing IT services to ensure compliance with internally defined standards.

Collaboration with Corporate Audit

• Work with the Corporate Audit function to assess and analyze IT findings from internal and external audits and assist in the identification of IT-related audit issues and provide input on corrective action plans support audit efforts by providing documentation evidence and explanations related to IT compliance activities.

Collaboration with IT Risk Management

• Partner with the IT Risk Management team to identify and assess IT compliance and security risks.

• Provide recommendations and support for the development and implementation of risk mitigation strategies and controls and assist in the preparation of risk assessments and ensure that appropriate ITGCs are in place to manage identified risks.

Regulatory Compliance and Continuous Improvement

• Continuously assess the effectiveness of existing compliance controls recommend improvements to enhance security and efficiency and keep your knowledge up to date and assist in the preparation for and coordination of regulatory inspections or audits.

AI Compliance

• Stay updated on evolving regulatory requirements for AI in GxP finance and other regulated environments.

• Work closely with internal AI Center of Excellence and cross-functional teams to align AI initiatives with compliance requirements and ensure compliance of AI systems and applications with internal and external governance frameworks.

• Promote AI Compliance Awareness: Develop and deliver training on AI compliance requirements risks and best practices. Foster a culture of responsible AI use and compliance across the organization ensuring teams understand the implications of AI in their workflows.

Training and Awareness

• Develop and deliver training materials to ensure business units are educated about IT compliance requirements policies and controls and promote a culture of compliance awareness across the organization.

Documentation and Reporting

• Maintain comprehensive documentation of all IT compliance activities including risk assessments control testing and audit findings and prepare periodic compliance reports for senior management outlining key issues risks and status of mitigation actions.

Qualifications

Education

• Masters degree in Information Technology Computer Science Business Administration or related field.

• A relevant compliance certification (e.g. CISA CISM CISSP) is of advantage.

Experience

• Minimum of 5 years of experience in IT compliance IT audit or risk management with a focus on SAP finance systems; experience with GxP systems of advantage.

• Experience working with audit functions and cross-functional teams to identify and resolve IT compliance issues.

• Experience with AI governance validation and risk management in regulated industries.

• Solid understanding of IT risk management practices controls and frameworks (e.g. COSO COBIT).

Skills

• Strong analytical skills with the ability to assess complex IT and business processes for compliance risks.

• Excellent communication skills with the ability to explain technical concepts to non-technical stakeholders.

• Detail-oriented with strong organizational and documentation skills.

Preferred Qualifications

• Knowledge of SAP GRC (Governance Risk and Compliance) or similar compliance management tools.

• Experience in life sciences or pharmaceutical industries with a focus on GxP-compliant systems.

Why join our team

At Fresenius Kabi compliance and quality are the foundation of our mission to improve patient care this role you will have a direct impact on the security and reliability of critical IT systems that support our global operations. You will work closely with international teams and contribute to the continuous development of a strongfuture orientedcompliance landscape.

Ready to join us

Apply now via our online portal.
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