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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.

Key Responsibilities

Strategic & Solution Leadership

+ Serve as the Solution Owner and functional expert for integrated systems, including SAP S/4HANA, SAP CGTO, Salesforce ATM, and Enterprise MDM.

+ Define the architecture, solution design, and technical roadmap for critical GxP systems supporting Clinical Supply Chain, Commercial Operations, Quality Management, and Manufacturing.

+ Lead the integration strategy and execution between SAP S/4HANA (covering Supply Chain, Finance, and Manufacturing), Salesforce ATM (for Patient/Order/Cell Orchestration), SAP CGTO, and other GxP systems.

+ Translate complex business requirements related to Chain of Custody (CoC) and Chain of Identity (CoI)—crucial in CGT—into compliant and scalable system solutions.

GxP, Quality & Compliance

+ Own and enforce GxP compliance for all in-scope applications, ensuring all system activities meet requirements for validation, change control, documentation, audit trails, and data integrity.

+ Directly manage the System Development Life Cycle (SDLC) for regulated systems, including validation planning, executing IQ/OQ/PQ protocols, and final report generation.

+ Act as the primary point of contact during regulatory inspections and internal GxP audits related to the managed systems.

+ Establish and govern processes for Master Data Quality and Governance across the enterprise, ensuring data integrity is maintained for GxP-critical data elements.

Management & Execution

+ Lead and mentor a cross-functional team of business analysts, functional consultants, and system integrators.

+ Oversee project execution, managing scope, budget, resources, and timelines for major system initiatives and enhancements.

+ Manage vendor relationships and service delivery for external partners involved in system implementation and support.

Required Qualifications

Experience & Functional Expertise

+ 8+ years of experience in implementing and managing enterprise systems within the Pharmaceutical, Biotech, or Cell/Gene Therapy industry.

+ Proven expertise in leading major transformation projects involving SAP S/4HANA (Sourcing, SC, QM, MM, SD modules).

+ Direct, hands-on experience with Salesforce Health Cloud and/or Advanced Therapy Management (ATM), particularly concerning patient and cell journey orchestration.

+ Deep practical knowledge of GxP regulations (21 CFR Part 11, GAMP 5, etc.) and demonstrated experience validating regulated computer systems.

+ Strong understanding of Master Data Management (MDM) principles and experience implementing an MDM solution in a regulated environment.

+ Specific knowledge of CGT processes, including CoC/CoI, apheresis, vector manufacturing, and final product distribution, is highly desirable.

Education & Technical Skills

+ Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or a related field.

+ Exceptional ability to manage system integration complexity, with a background in technologies like SAP CPI platform.

+ Outstanding leadership, communication, and stakeholder management skills, with the ability to articulate complex technical concepts to a non-technical audience.

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.

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.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]

This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our** **Mission

_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_

Our** **Vision

_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_