Senior System Analyst, Enterprise Applications

Sumitomo Pharma Co., Ltd. is a dynamic global pharmaceutical company based in Japan, dedicated to meeting patient needs across various therapeutic areas including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a portfolio of marketed products and a broad pipeline of investigational assets, our mission is to accelerate the discovery and development of innovative therapies for patients. For more information, please visit our career page. Senior System Analyst, Enterprise Applications Job Overview We are looking for a detail-oriented and experienced Senior System Analyst to oversee the governance and compliance lifecycle of our GxP-critical SAP Enterprise Applications. This pivotal role focuses on maintaining our validated state through effective management of Change Control, Test Execution, and all essential GxP documentation related to our SAP S/4HANA systems utilized in Manufacturing, Quality, and Supply Chain operations. Responsibilities GxP Documentation & Quality System Management Documentation Authoring: Lead the creation, review, and maintenance of all essential GxP documentation, such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and policy documents. Requirements & Design: Collaborate with business users to draft User Requirements Specifications (URS) and convert them into comprehensive Functional Specifications (FS). Audit Support: Ensure the document repository is well-maintained, complete, and ready for regulatory inspections. Change Control & Execution Leadership Change Management Process: Spearhead the change control process for SAP modifications from start to finish. Impact Assessment: Perform in-depth Impact Assessments on GxP changes to evaluate potential risks. Change Control Board (CCB): Engage in CCB meetings, documenting decisions and securing necessary approvals. Execution & Coordination: Lead the generation of change requests and ensure effective execution of changes. Testing, Validation & Compliance Execution Test Documentation: Create and maintain thorough Test Documentation, including detailed test scripts and traceability matrices. Test Execution: Oversee validation testing and ensure accurate documentation of results. Compliance Expertise: Guarantee adherence to GxP regulations and standards. Collaboration & SAP Functional Support Stakeholder Liaison: Act as the main point of contact between IT, QA, and business owners to ensure smooth change implementation. Configuration Support: Assist in configuring SAP S/4HANA modules pertinent to pharmaceutical operations. System Improvement: Suggest process enhancements to streamline operations while upholding compliance. Key Competencies In-depth SAP functional knowledge with a strong focus on compliance. End-to-end ownership of GxP-regulated applications. Expertise in validation documentation and test execution. Ability to proactively identify and mitigate system risks. Collaboration skills with various stakeholders across departments. Education and Experience Required Skills 5+ years of experience in a relevant role supporting SAP ERP systems, especially SAP S/4HANA. 5+ years of direct experience in GxP Change Control and Validation execution. Strong understanding of GxP regulations. Proficiency in authoring GxP Documentation. Familiarity with two or more SAP modules relevant to the pharmaceutical industry. Excellent analytical, communication, and interpersonal skills. Preferred Skills Experience with SAP Change Management tools and QMS integration. Relevant SAP or ITIL certifications. The base salary for this role ranges from $99,400 to $123,800. This is part of our comprehensive rewards package including merit-based salary increases, benefits, and a robust time-off policy. We are committed to ensuring our hiring process is accessible to all candidates. Visit us to learn more about our mission, vision, and values.

Created: 2026-03-04