Manager, Enterprise Apps

1. GxP Validation & Compliance Leadership

• Validation Protocol and Testing Management: Own the GxP validation lifecycle for all relevant SAP S/4
  
  HANA modules and integrated systems (e.g., IRT). This includes developing, managing, and securing approval for all validation documentation (Validation Plans, UAT Scripts, Traceability Matrices, Summary Reports).

• Protocol Execution: 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.

• Audit Readiness: Serve 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.

• Compliance Assessment: Conduct GxP compliance assessments for new SAP system features, configurations, and processes, ensuring adherence to regulations such as 21 CFR Part 11, GxP.

2. Integrated Supply Chain & Manufacturing Solution Design

• Functional Leadership: 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 of SAP S/4
  
  HANA with external enterprise systems and third-party applications, particularly Interactive Response Technology (IRT) systems used in clinical trials.

• Electronic Batch Records (eBRs): Design and implement e  functionalities within SAP, ensuring complete data integrity and traceability throughout the manufacturing process.

3. Deployment Readiness, Testing & Quality Assurance

• Site Readiness: 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.

• Testing Management: Develop comprehensive test plans (Unit, Integration, and User Acceptance Testing) and manage the entire testing phase.

• Execution Leadership: Lead the execution of all test scenarios, encompassing both Non-Validated and Validated Test scenarios.

• Defect Resolution: Own the defect management lifecycle, prioritizing, tracking, and coordinating the resolution of issues with functional and technical teams.

• Data Integrity & Migration: 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.

4. Business Collaboration & Management

• Requirement 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.

• Process Optimization: Analyze existing business processes, identify opportunities for improvement utilizing standard SAP functionalities, and drive continuous optimization initiatives.

• Team Leadership: Manage and mentor project team members, external consultants, and internal functional analysts. Manage project timelines, budgets, and resources.