Sumitomo Pharma Co., Ltd. is a leading global pharmaceutical company dedicated to meeting patient needs across various therapeutic areas, including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a strong portfolio of marketed products and a robust pipeline, we are committed to accelerating the development of innovative therapies. For more insight into our mission, visit our website or connect with us on LinkedIn.
Position: Enterprise Applications Lead
Job Overview
We are seeking a compliance-oriented SAP S/4HANA Solution and Functional Manager to oversee and enhance our essential pharmaceutical operations, including commercial and clinical supply chains, manufacturing, inventory, quality management systems, and forecasting. This vital role involves aligning strategy, ensuring compliance in SAP S/4HANA deployment, and driving continuous improvement. Key responsibilities include leading site readiness for SAP implementation, managing testing and defect resolutions, and overseeing the GxP Validation documentation and execution process. Exceptional expertise in SAP and strong knowledge of regulatory requirements are essential for success in this role.
Key Responsibilities
GxP Validation & Compliance Leadership
Validation Protocol and Testing Management:
Oversee the GxP validation lifecycle for SAP S/4HANA modules, developing and securing approval for validation documentation. Protocol Execution:
Direct the execution of all GxP Protocols (IQ, OQ, PQ) and coordinate with cross-functional teams to ensure successful outcomes. Audit Readiness:
Act as the primary SAP GxP expert during inspections and audits, ensuring all documentation is audit-ready. Compliance Assessment:
Evaluate GxP compliance for new SAP features and processes in adherence to industry standards. Integrated Supply Chain & Manufacturing Solution Design Functional Leadership:
Lead the analysis, design, and implementation of SAP S/4HANA across supply chain logistics, planning, and quality management. Supply Chain:
Oversee commercial and clinical logistics, Inventory Management (IM), and Extended Warehouse Management (EWM). Planning & Forecasting:
Utilize SAP and other planning tools for demand and inventory optimization. Manufacturing (PP/PM):
Manage production planning, scheduling, and master data functions. Quality Management (QM):
Implement Quality Management System processes in SAP. IRT & External System Integration:
Oversee the integration of SAP with external systems, especially in clinical trials. Electronic Batch Records (eBRs):
Design eBR functionalities in SAP for data integrity. Deployment Readiness, Testing & Quality Assurance Site Readiness:
Manage site preparedness for SAP deployment, including process alignment and localization. Testing Management:
Develop testing plans and lead the testing process effectively. Execution Leadership:
Guide all test scenarios, ensuring thorough validation. Defect Resolution:
Manage and prioritize defect resolutions with relevant teams swiftly. Data Integrity & Migration:
Oversee data transfers from legacy systems, ensuring accuracy and compliance. Business Collaboration & Management Requirement Management:
Lead workshops with stakeholders to gather requirements and develop functional specifications. Process Optimization:
Identify improvement opportunities in business processes utilizing SAP functionalities. Team Leadership:
Manage and mentor team members, ensuring efficient project timelines and resource management. Education and Experience Required Experience & Skills 8+ years of experience in SAP ERP implementations with a focus on S/4HANA. Deep expertise in integrated supply chain modules including PP, MM, QM, and EWM. Strong GxP validation experience, including protocol drafting and execution. Proven experience managing large-scale testing efforts and defect resolutions. Excellent knowledge of pharmaceutical regulations and GxP compliance. Strong analytical, communication, and problem-solving abilities. Able to effectively manage multiple priorities in a fast-paced environment. Preferred Skills Experience with SAP Business Technology Platform and Fiori app development. Familiarity with advanced planning solutions like Kinaxis. SAP S/4HANA certification in relevant modules. Knowledge of specific pharmaceutical processes such as Serialization and IRT integration. The base salary range for this role is $125,600 to $157,000, with additional benefits including merit-based increases, 401(k) participation, insurance coverage, and a comprehensive time-off policy. Total compensation will be tailored to the candidate's qualifications and experience. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer . We ensure consideration for employment without discrimination based on any legally protected characteristic. Mental/Physical Requirements:
The role involves working in a fast-paced environment where multitasking and exercising judgment are essential. Strong communication skills and prolonged computer use are necessary.
Oversee the GxP validation lifecycle for SAP S/4HANA modules, developing and securing approval for validation documentation. Protocol Execution:
Direct the execution of all GxP Protocols (IQ, OQ, PQ) and coordinate with cross-functional teams to ensure successful outcomes. Audit Readiness:
Act as the primary SAP GxP expert during inspections and audits, ensuring all documentation is audit-ready. Compliance Assessment:
Evaluate GxP compliance for new SAP features and processes in adherence to industry standards. Integrated Supply Chain & Manufacturing Solution Design Functional Leadership:
Lead the analysis, design, and implementation of SAP S/4HANA across supply chain logistics, planning, and quality management. Supply Chain:
Oversee commercial and clinical logistics, Inventory Management (IM), and Extended Warehouse Management (EWM). Planning & Forecasting:
Utilize SAP and other planning tools for demand and inventory optimization. Manufacturing (PP/PM):
Manage production planning, scheduling, and master data functions. Quality Management (QM):
Implement Quality Management System processes in SAP. IRT & External System Integration:
Oversee the integration of SAP with external systems, especially in clinical trials. Electronic Batch Records (eBRs):
Design eBR functionalities in SAP for data integrity. Deployment Readiness, Testing & Quality Assurance Site Readiness:
Manage site preparedness for SAP deployment, including process alignment and localization. Testing Management:
Develop testing plans and lead the testing process effectively. Execution Leadership:
Guide all test scenarios, ensuring thorough validation. Defect Resolution:
Manage and prioritize defect resolutions with relevant teams swiftly. Data Integrity & Migration:
Oversee data transfers from legacy systems, ensuring accuracy and compliance. Business Collaboration & Management Requirement Management:
Lead workshops with stakeholders to gather requirements and develop functional specifications. Process Optimization:
Identify improvement opportunities in business processes utilizing SAP functionalities. Team Leadership:
Manage and mentor team members, ensuring efficient project timelines and resource management. Education and Experience Required Experience & Skills 8+ years of experience in SAP ERP implementations with a focus on S/4HANA. Deep expertise in integrated supply chain modules including PP, MM, QM, and EWM. Strong GxP validation experience, including protocol drafting and execution. Proven experience managing large-scale testing efforts and defect resolutions. Excellent knowledge of pharmaceutical regulations and GxP compliance. Strong analytical, communication, and problem-solving abilities. Able to effectively manage multiple priorities in a fast-paced environment. Preferred Skills Experience with SAP Business Technology Platform and Fiori app development. Familiarity with advanced planning solutions like Kinaxis. SAP S/4HANA certification in relevant modules. Knowledge of specific pharmaceutical processes such as Serialization and IRT integration. The base salary range for this role is $125,600 to $157,000, with additional benefits including merit-based increases, 401(k) participation, insurance coverage, and a comprehensive time-off policy. Total compensation will be tailored to the candidate's qualifications and experience. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer . We ensure consideration for employment without discrimination based on any legally protected characteristic. Mental/Physical Requirements:
The role involves working in a fast-paced environment where multitasking and exercising judgment are essential. Strong communication skills and prolonged computer use are necessary.