Manager, Enterprise Apps

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.

Job Overview

• 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.

• 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.

• 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.

• 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.

• Minimum of 4 years experience implementing and configuring ERP systems, with strong preference for SAP ERP configuration experience.

• Proven, deep expertise in SAP modules relevant to integrated supply chain, such as 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.

• 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).

The base salary range for this role is $125,600 to $157,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes 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.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.