Sr. System Analyst, Enterprise Apps, Tech Ops

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

• 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.

Key Core Competencies

• The ideal candidate possesses deep SAP functional knowledge, exceptional attention to detail, and a proven ability to collaborate with Quality Assurance (QA) and business stakeholders to ensure every system modification adheres to global pharmaceutical regulations.

• 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.

• Minimum of 3+ years of experience in a System Analyst, Business Analyst, or Functional Consultant role supporting SAP ERP systems, with significant exposure to SAP S/4HANA.

• 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.

• 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.

The base salary range for this role is $112,700 to $140,900. 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.