Manager, Enterprise Apps

Manager, Enterprise Applications

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with operations in the U.S. (Sumitomo Pharma America, Inc.), addressing patient needs in oncology, urology, women’s health, rare diseases, cell & gene therapies and CNS. We aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

We are seeking a highly accomplished and compliance-driven SAP S/4

HANA Solution and Functional Manager to manage and optimize our core pharmaceutical operations spanning the Commercial and Clinical Supply Chain, Manufacturing, Inventory, Quality Management Systems, Planning and Forecasting. This critical management role is accountable for ensuring the strategic alignment, compliant deployment, and continuous improvement of SAP S/4

HANA across these functions. A primary focus will be leading site readiness for SAP deployment, driving all testing and defect resolution efforts, and managing the entire GxP Validation protocol documentation and execution lifecycle. This position demands exceptional SAP expertise combined with deep regulatory knowledge.

• GxP Validation & Compliance Leadership
  • Own the GxP validation lifecycle for all relevant SAP S/4
    
    HANA modules and integrated systems (e.g., IRT). Develop, manage, and secure approval for all validation documentation (Validation Plans, UAT Scripts, Traceability Matrices, Summary Reports).
  • Lead the execution of all GxP Protocols (IQ, OQ, PQ) and coordinate cross-functional teams (Quality Assurance, Business Owners, IT) to ensure successful execution and proper sign-off.
  • as the primary SAP GxP subject matter expert during internal and external regulatory inspections and audits. Ensure all SAP documentation and procedures are continuously audit-ready.
  • Conduct GxP compliance assessments for new SAP system features, configurations, and processes, ensuring adherence to regulations such as 21 CFR Part 11, GxP.
• Integrated Supply Chain & Manufacturing Solution Design
  • Lead the analysis, design, configuration, and implementation of complex SAP S/4
    
    HANA solutions across the following modules/areas:
    Supply Chain (Commercial and Clinical supply logistics, Inventory Management (IM), Extended Warehouse Management (EWM)), Planning & Forecasting (strategic utilization of SAP and Non-SAP Planning tools to manage demand, production, and inventory optimization), Manufacturing (PP/PM) (production planning, scheduling, execution, and master data management (BOMs, Routings)), Quality Management (QM) (implementation of QMS processes within SAP, including batch records, material release, non-conformance, and deviation management), IRT & External System Integration (lead the integration with IRT systems used in clinical trials), Electronic Batch Records (eBRs) (design and implement e  functionalities within SAP, ensuring complete data integrity and traceability).
• Deployment Readiness, Testing & Quality Assurance
  • Lead all aspects of site readiness for SAP deployment at manufacturing facilities, distribution centers, and clinical sites, including process alignment, localized configuration, and cutover planning.
  • Develop comprehensive test plans (Unit, Integration, and User Acceptance Testing) and manage the entire testing phase.
  • Lead the execution of all test scenarios, encompassing both Non-Validated and Validated Test scenarios.
  • Own the defect management lifecycle, prioritizing, tracking, and coordinating the resolution of issues with functional and technical teams.
  • Manage and oversee the transfer of master data (materials, vendors, etc.) and transactional data from legacy systems, ensuring data accuracy and regulatory compliance post-migration.
• Business Collaboration & Management
  • Lead design workshops and collaborate with business stakeholders (Manufacturing, Quality, Supply Chain Planning) to translate complex business needs and pain points into detailed functional specifications and configuration strategies.
  • Analyze existing business processes, identify opportunities for improvement utilizing standard SAP functionalities, and drive continuous optimization initiatives.
  • Manage and mentor project team members, external consultants, and internal functional analysts. Manage project timelines, budgets, and resources.

• Required Experience & Skills
  • Minimum of 8 years of experience in implementing and configuring SAP ERP systems, with a strong focus on SAP S/4
    
    HANA deployments.
  • Proven, deep expertise in SAP modules relevant to integrated supply chain, including PP, MM, QM, EWM/WM, and Kinaxis and other Clinical Planning Application (Planning and Forecasting).
  • Demonstrated GxP Validation Leadership with hands‑on experience in drafting, managing, and executing validation protocols (IQ, OQ, PQ) within a pharmaceutical environment.
  • Extensive experience leading large-scale testing efforts (SIT, UAT) and managing defect resolution and traceability.
  • Excellent understanding of pharmaceutical industry…