Manager, Enterprise Apps

Sumitomo Pharma•Marlborough, NC

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Manager, Enterprise Applications Job Overview We are seeking a highly accomplished and compliance-driven SAP S/4HANA 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/4HANA 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.

Requirements

Minimum of 8+ years of experience in implementing and configuring SAP ERP systems, with a strong focus on SAP S/4HANA deployments.
Proven, deep expertise in SAP modules relevant to integrated supply chain, including PP (Production Planning), MM (Materials Management), QM (Quality Management), EWM/WM (Warehouse Management), 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 regulations, GxP compliance, and the requirements for electronic records (21 CFR Part 11).
Strong analytical, problem-solving, and communication skills, with the ability to bridge the gap between technical teams and business leadership.
Ability to manage multiple priorities and work effectively under pressure in a fast-paced environment.

Nice To Haves

Experience with SAP Business Technology Platform (BTP) applications or Fiori app development.
Experience with advanced planning solutions (Kinaxis).
Certification in relevant SAP S/4HANA modules (e.g., PP/QM/SCM).
Experience with specific pharmaceutical processes like Serialization, IRT integration, and Cell/Gene Therapy processes (CGTO).

Responsibilities

GxP Validation & Compliance Leadership
Validation Protocol and Testing Management: Own the GxP validation lifecycle for all relevant SAP S/4HANA 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.
Integrated Supply Chain & Manufacturing Solution Design
Functional Leadership: Lead the analysis, design, configuration, and implementation of complex SAP S/4HANA 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/4HANA 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 eBR functionalities within SAP, ensuring complete data integrity and traceability throughout the manufacturing process.
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.
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.

Benefits

opportunity for merit-based salary increases
short incentive plan participation
eligibility for our 401(k) plan
medical, dental, vision, life and disability insurances
leaves provided in line with your work state
flexible paid time off
11 paid holidays plus additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume