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Oversee and ensure the integrity of IT systems by implementing IT General Controls (ITGCs) for SAP, finance, and GxP-regulated systems. Collaborate with Corporate Audit and IT Risk Management to mitigate compliance risks and align AI initiatives with governance frameworks.
Requires a Master's degree in IT, Computer Science, or Business and at least 5 years of experience in IT compliance or audit. Proficiency in SAP, GxP systems, and risk frameworks like COSO or COBIT is essential, with AI governance experience being a plus.
We are seeking an 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 systems. In 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.
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.
Education
Master's 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 worldwide. In 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 strong, future oriented compliance landscape.
Ready to join us?
Apply now via our online portal.
#futurefresenius
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 43,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit www.fresenius-kabi.com/us.
Offices: 3 Corporate Drive, Lake Zurich, Illinois 60047, US · 3159 Staley Rd, Grand Island, New York 14072, US · 2020 Ruby St, Melrose Park, Illinois 60164, US · LLC, 20 Dan Rd, Ste 1, Canton, MA 02021, US · 5200 Corporate Pkwy W, Wilson, North Carolina 27893, US
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