Sumitomo Pharma America, Inc. · 8 hours ago
Sr. System Analyst, Enterprise Apps, Tech Ops
United States
Full-time
Remote
Mid, Senior Level
$99K/yr - $124K/yr
5+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various therapeutic areas. They are seeking an experienced Senior System Analyst to manage the governance, documentation, and compliance of GxP-critical SAP Enterprise Applications, ensuring regulatory adherence and effective change control processes.
Pharmaceuticals
Responsibilities
Lead the development, review, and maintenance of all GxP-critical documentation, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and associated policy documents for SAP system usage and support
Collaborate directly with business users to finalize User Requirements Specifications (URS) and translate them into detailed Functional Specifications (FS) for system changes, ensuring traceability to testing protocols
Maintain the document repository to ensure all validation and change records are complete, accurate, and readily available for internal and external regulatory inspections (e.g., FDA, EMA)
Lead the change control process for all SAP system modifications (implementations, upgrades, config changes, system enhancements) from inception to deployment
Conduct thorough Impact Assessments for all proposed GxP system changes to identify potential risks to the validated state, data integrity, and regulatory compliance
Participate the Change Control Board (CCB) process, facilitating meetings, documenting decisions, and ensuring necessary functional and QA approvals are obtained before implementation
Assist with the generation of change requests, lead the actual Change Execution in the system, and coordinate technical and functional teams to ensure timely and compliant implementation
Prepare and maintain comprehensive Test Documentation, including creation of detailed test scripts (IQ/OQ/PQ) and traceability matrices, ensuring alignment with URS and FS
Lead and perform the execution of validation testing (IQ, OQ, PQ) and coordinate integration and system-level tests, ensuring all results and deviations are properly documented and resolved
Support GxP applications and systems, ensuring adherence to regulatory standards such as GAMP 5, 21 CFR Part 11 (Electronic Records and Signatures), Computer System Validation (CSV) principles, and evolving guidance from regulatory bodies
Act as the primary liaison between IT functional teams, Quality Assurance (QA), and key business process owners (Manufacturing, Quality, Supply Chain) to facilitate smooth change implementation
Provide functional support by assisting in the configuration and customization of SAP S/4HANA modules relevant to pharmaceutical operations (e.g., QM, PP, MM, SD)
Propose alternate processes and procedures to streamline IT operations, increase efficiency, and ensure systems are optimized while remaining compliant
Qualification
Required
Minimum of 5+ years of experience in a System Analyst, Business Analyst, or Functional Consultant role supporting SAP ERP systems, with significant exposure to SAP S/4HANA
5 + years of direct, hands-on experience leading GxP Change Control and Validation execution within the pharmaceutical, biotech, or life sciences industry
Expertise in GxP regulations including 21 CFR Part 11, GAMP 5, and Computer System Validation principles
Proven experience in authoring GxP Documentation (SOPs, WIs, URS, FS, Test Scripts, Validation Protocols)
Deep functional knowledge of at least two core SAP modules relevant to Pharma (e.g., QM, PP, MM, SD)
Strong analytical and problem-solving skills, with an exceptional ability to focus on detail and documentation accuracy
Excellent communication and interpersonal skills, with proven ability to collaborate effectively with Quality Assurance and senior business stakeholders
Preferred
Experience with SAP Change Management tools (e.g., SAP Solution Manager/CHARM) and Cloud ALM
Experience with Quality Management Systems (QMS) integration with SAP (e.g., Veeva Quality)
Experience with SAP Business Technology Platform (BTP) applications
Relevant SAP or ITIL certifications
Benefits
Merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
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
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesH1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (14)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
Company data provided by crunchbase