Sr. System Analyst, Enterprise Apps, Tech Ops

Sumitomo Pharma•Marlborough, MA

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. Senior System Analyst, Enterprise Apps, Tech Ops Job Overview We are seeking an experienced and meticulous Senior System Analyst to serve as the primary expert responsible for the governance, documentation, and compliance lifecycle of our GxP-critical SAP Enterprise Applications. This role is central to maintaining our validated state by rigorously managing Change Control, Test Execution, and all required GxP documentation (SOPs, Work Instructions, Protocols) for SAP S/4HANA systems used across Manufacturing, Quality, and Supply Chain.

Requirements

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.

Nice To Haves

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.

Responsibilities

GxP Documentation & Quality System Management Documentation Authoring: 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.
Requirements & Design: 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.
Audit Support: 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).
Change Management Process: Lead the change control process for all SAP system modifications (implementations, upgrades, config changes, system enhancements) from inception to deployment.
Impact Assessment: Conduct thorough Impact Assessments for all proposed GxP system changes to identify potential risks to the validated state, data integrity, and regulatory compliance.
Change Control Board (CCB): Participate the Change Control Board (CCB) process, facilitating meetings, documenting decisions, and ensuring necessary functional and QA approvals are obtained before implementation.
Execution & Coordination: 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.
Test Documentation: Prepare and maintain comprehensive Test Documentation, including creation of detailed test scripts (IQ/OQ/PQ) and traceability matrices, ensuring alignment with URS and FS.
Test Execution: 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.
Compliance Expertise: 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.
Stakeholder Liaison: 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.
Configuration Support: 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).
System Improvement: Propose alternate processes and procedures to streamline IT operations, increase efficiency, and ensure systems are optimized while remaining compliant.
Provide end‑to-end ownership of GxP‑regulated enterprise applications supporting Quality (QMS, Document Control, Training, Deviation/CAPA, Supplier Quality, Batch Release, etc.).
Veeva Quality & T&Q Application Ownership Lead test strategy, planning, and execution for SAP releases, enhancements, and integrated applications.
Oversee test documentation, scripts, traceability, and defect management to ensure completeness and GxP compliance.
Ensure alignment with CSV (Computer System Validation) and cGMP expectations when testing impacts GxP processes.
Partner with SAP functional leads and business process owners to ensure risk‑based testing coverage.
Lead development, review, and approval of validation documentation (URS, FS, DS, IQ/OQ/PQ, test scripts).
Maintain stringent controls over protocol execution and documentation integrity.
Establish governance processes for change control, periodic review, system monitoring, and release readiness.
Ensure electronic records and signatures comply with regulatory requirements.
Proactively identify system risks, gaps, and compliance exposures; drive mitigation actions.
Collaborate closely with Quality, Manufacturing, Supply Chain, Regulatory, and IT leaders.
Translate business needs into system requirements and scalable solutions.

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

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