Our client is Siemens Healthineers, a leading global medical technology company with more than 55,000 dedicated colleagues in over 70 countries, driven to shape the future of healthcare.
The Center of Excellence (CoE) SAP provides various major business critical systems and platforms for SHS’s business areas & business lines. Therefore, the highest quality and audit conformity are essential and as global acting medical device manufacturer, US FDA Article 21 must be fulfilled too.
Within CoE SAP, the department CAS (Compliance, Authorization & Security) proactively governs, monitors & consult regarding SAP Quality, Compliance & Audit towards business and IT by providing expert knowledge, defined frameworks & innovative tool sets to safeguard SAP systems' integrity & security!
Quality & Compliance are accountable for the strategic and operational performance of the CAS department, ensuring the successful delivery of business strategy and operational goals to exceed customer expectations for product/process quality, cost, and delivery while facilitating continuous improvement.
RESPONSIBILITIES AND TASKS:
You support the departments governing function for all SAP System-related quality & compliance topics, including constantly monitoring & reporting on potential risks and threats for a timely escalation and resolution.
You will work in a team of Quality, Audit- and Compliance-Experts managing, supporting & coordinating all activities related to internal & external SAP Quality-& compliance audits including necessary remediation activities
You will collaborate closely with all SAP System Owners, SHS Audit, external audit partners (e.g. EY, FDA), other SHS IT departments and CoE SAP Executive Team to resolve issues and achieve quality-, compliance- & audit conformity
You will be responsible for certain IT Service Mgmt. Lifecycle Process incl. SAP document control and records management, ensuring that necessary documents/records for IT regulated SAP Systems (ITCCS) are created, reviewed (up-to-date), stored (e.g. in SAP Solution Manager, CMDB), distributed and disposed of in a systematic, verifiable manner fulfilling the QMP / Requirement Specification
You monitor and coach the SAP CAPA process (Corrective and Preventive Action) to successful completion using 5D methodology in connection with Problem Management.
You will be responsible for CoE SAP System’s P2P Compliance tasks and centrally drive framework implementation and violation remediation of Segregation of Duties (SoD), Preventative Application Controls (PAC) and Continuous Controls Monitoring (CCM)
You will execute system specific Operational Manual Reviews, Asset classification & protection assessments (ACP/CAP), Quality Mgmt. Process Reviews and Quality-Awareness-Trainings for CoE SAP.
You collect and analyze the quality performance in processes (KPIs) and promote quality improvement. You initiate actions according to the result of statistical data.
YOUR QUALIFICATIONS AND EXPERIENCE:
You have successfully completed a bachelor’s degree in the field of Information Systems, Business Administration, Computer Science or similar
You have several years of professional experience in IT Quality Mgmt. Systems & regulations (FDA Part 820 QSR, 21 CFR Part 820 (Part11), SOA/SOX 404, ITGC). Certifications from notified bodies preferred, e.g. QSR Training as ASQ, AAMI, RAPS
You have several years of professional experience in IT Quality Mgmt. & Compliance, preferable as internal Auditor/Lead Auditor. Certifications from notified bodies preferred, e.g. ISACA CISA, ASQ
You have deep knowledge about SAP ERP (Modules FI/CO/MM/SD, Basis), SAP Master Data Governance (MDG) and SAP Solution Manager (SolMan)
You have solid know how about IT Service Management, ITIL V3 and IT Compliance
You are familiar with ISO9001/27001 and the regulatory requirements for non-product software of a global healthcare products and services business
You have experience in ext. Service Provider- & Partner Mgmt.
