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Über
Oversee the GxP validation lifecycle for SAP S/4HANA modules, including 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 to adhere to industry standards. 2. 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. Quality Management (QM):
Implement Quality Management System processes in SAP. IRT & External System Integration:
Oversee integration of SAP with external systems, especially in clinical trials. Electronic Batch Records (eBRs):
Design eBR functionalities in SAP for data integrity. 3. 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. Execution Leadership:
Guide all test scenarios, ensuring validation. Defect Resolution:
Manage and prioritize defect resolutions with relevant teams. Data Integrity & Migration:
Oversee data transfers from legacy systems, ensuring accuracy and compliance. 4. Business Collaboration & Management Requirement Management:
Lead workshops with stakeholders to gather requirements and develop functional specifications. Process Optimization:
Identify improvement opportunities in business processes using 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 in 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 manage multiple priorities effectively 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.
Sprachkenntnisse
- English
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