Enterprise Applications Manager, Tech Operations

Sumitomo Pharma

United States

United States

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Über

Sumitomo Pharma Co., Ltd. is a leading global pharmaceutical company committed to addressing patient needs in critical areas such as oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a diverse range of marketed products and a robust pipeline of investigational assets, we are dedicated to accelerating research, discovery, and development to bring innovative therapies to patients as quickly as possible. 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 Master Data Management (MDM). Define architecture, solution design, and technical roadmap for critical GxP systems that support Clinical Supply Chain, Commercial Operations, Quality Management, and Manufacturing. Lead the strategy and execution for integrating SAP S/4HANA, Salesforce ATM, SAP CGTO, and other GxP systems. Convert complex business requirements regarding Chain of Custody and Chain of Identity into compliant and scalable system solutions. GxP, Quality & Compliance Ensure all in-scope applications comply with GxP standards, including validation, change control, documentation, audit trails, and data integrity. Manage the System Development Life Cycle (SDLC) for regulated systems, including planning validation, executing IQ/OQ/PQ protocols, and generating final reports. Act as the primary contact during regulatory inspections and internal GxP audits for managed systems. Establish and oversee processes for Master Data Quality and Governance across the enterprise, ensuring data integrity for GxP-critical 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 enhancements. Manage vendor relationships and service delivery for 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 industries. Proven expertise in leading major transformation projects using SAP S/4HANA (Sourcing, Supply Chain, Quality Management, Material Management, Sales and Distribution modules). Hands-on experience with Salesforce Health Cloud and/or Advanced Therapy Management, especially in patient and cell journey orchestration. Strong understanding of GxP regulations (21 CFR Part 11, GAMP 5, etc.) and experience validating regulated computer systems. Proficient in Master Data Management principles with experience in implementing MDM solutions in regulated environments. Knowledge of CGT processes, like Chain of Custody and Chain of Identity, apheresis, vector manufacturing, and product distribution, is advantageous. 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 such as the SAP CPI platform. Outstanding leadership, communication, and stakeholder management skills, able to explain complex technical concepts to non-technical audiences. The base salary range for this role is $125,600 to $157,000. Base salary is part of our total rewards package which includes opportunities for merit-based salary increases, participation in a short incentive plan, eligibility for our 401(k) plan, and various forms of insurance and paid time off. Total compensation will be determined by candidate experience, skills, education, and other legally permitted factors. Disclaimer:
The above statements are intended to describe the general nature and responsibilities of this role, and are not exhaustive lists of all duties and skills required. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data:
All information encountered in this role is considered confidential. Compliance:
Maintain compliance with applicable regulatory, legal, and operational guidelines by upholding best industry practices and 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:
Work in a fast-paced environment handling multiple demands requires exercising sound judgment, independence, and initiative. Excellent written and oral communication skills are essential, as is the ability to use a personal computer for extended periods. Sumitomo Pharma America is an Equal Employment Opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, marital status, sex, gender, affectional or sexual orientation, disability, veteran status, or any other characteristic protected by law. Sumitomo Pharma America endeavors to make its application process accessible to all. For assistance completing the application process or to discuss website accessibility, please contact us for accommodation requests only. At Sumitomo Pharma America, we are guided by our mission to contribute to society through innovative research and development for better healthcare worldwide.

United States

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English

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