Manager, Enterprise Applications Optimization

Sumitomo Pharma Co., Ltd. is a renowned global pharmaceutical company headquartered in Japan, actively engaged in addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a strong portfolio of marketed products and a promising pipeline of investigational assets, we are committed to accelerating research and development to bring innovative therapies to patients at an earlier stage. For more information, please visit our website or follow us on LinkedIn. Manager, Enterprise Applications Optimization Job Overview We are on the lookout for a highly skilled and compliance-oriented SAP S/4HANA Solution and Functional Manager to oversee and enhance our key pharmaceutical operations, including Commercial and Clinical Supply Chain, Manufacturing, Inventory Management, Quality Management Systems, and Planning and Forecasting. In this vital role, you will ensure strategic alignment, compliant deployment, and continuous enhancement of SAP S/4HANA across these functions. A key responsibility is leading site preparedness for SAP deployment, managing testing and defect resolution, as well as overseeing the complete GxP Validation documentation and execution lifecycle. This position demands not only exceptional SAP expertise but also a deep understanding of regulatory frameworks. Key Responsibilities GxP Validation & Compliance Leadership: Oversee the GxP validation lifecycle for all relevant SAP S/4HANA modules and integrated systems, including the development and approval of validation documentation and the execution of GxP Protocols (IQ, OQ, PQ), coordinating cross-functional teams to ensure successful outcomes. Audit Preparedness: Be the primary SAP GxP subject matter expert during regulatory inspections and audits, ensuring that all SAP documentation is continuously ready for audit conditions. Compliance Assessment: Perform GxP compliance assessments for new SAP features, ensuring adherence to regulations, including 21 CFR Part 11. Solution Design for Integrated Supply Chain & Manufacturing: Functional Leadership: Drive the analysis, design, configuration, and implementation of complex SAP S/4HANA solutions across various modules, encompassing Supply Chain logistics, Inventory Management, Planning & Forecasting, Manufacturing, and Quality Management. External System Integration: Manage the integration of SAP S/4HANA with external systems and third-party applications, with a particular focus on Interactive Response Technology (IRT) systems used in clinical trials. Electronic Batch Records: Design eBR functionalities within SAP to ensure data integrity and traceability during the manufacturing process. Deployment Readiness, Testing & Quality Assurance: Site Readiness: Lead all site readiness activities for SAP deployment, including alignment of processes, localized configurations, and planning for cutover. Testing Management: Generate comprehensive test plans and oversee the entire testing phase, ensuring both Validated and Non-Validated scenarios are executed efficiently. Data Integrity & Migration: Ensure the accuracy of master and transactional data transfer from legacy systems, maintaining regulatory compliance following data migration. Collaboration & Team Management: Requirement Management: Facilitate design workshops with business stakeholders to translate complex needs into functional specifications and configuration strategies. Process Optimization: Assess existing processes to identify and implement improvements leveraging standard SAP functionalities. Team Leadership: Mentor and manage project team members and external consultants, overseeing project timelines, budgets, and resource allocation. Qualifications and Experience Required Skills: 4+ years of experience in the ERP systems implementation and configuration, preferably in SAP. Proficiency in SAP modules related to integrated supply chain operations, including PP, MM, QM, EWM, as well as Clinical Planning Applications. Demonstrated leadership in GxP validation with proven experience in validation protocols within a pharmaceutical setting. Strong capability in managing extensive testing phases and defect resolution processes. In-depth knowledge of pharmaceutical regulations and GxP compliance, including 21 CFR Part 11. Excellent analytical, problem-solving, and communication skills. Preferred Qualifications: Experience with SAP Business Technology Platform (BTP) applications. Familiarity with advanced planning solutions such as Kinaxis. Certification in SAP S/4HANA modules. Experience with pharmaceutical processes like Serialization and IRT integration. The base salary range for this role is $125,600 to $157,000, along with a comprehensive rewards package including potential merit-based increases, incentive plan participation, and various health and wellness benefits. Our generous time-off policies encompass flexible PTO and paid holidays among several other perks. Compensation will be tailored to individual candidate experience and qualifications. Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer, dedicated to creating a diverse and inclusive work environment. Qualified candidates from all backgrounds will be considered without regard to race, gender, disability, or any other characteristic protected by law. This position involves a fast-paced environment requiring the ability to handle multiple demands while exercising sound judgment. Adept written and verbal communication skills are essential, as is the capacity to work with personal computers for extended periods.

Created: 2026-03-07