FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Senior System Analyst, Enterprise Apps, Tech Ops
Sumitomo Pharma America, Inc.Senior System Analyst managing GxP compliance lifecycle and SAP documentation. Collaborating with cross-functional teams and leading change control processes.
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Serve as the primary expert responsible for governance, documentation, and compliance lifecycle of GxP-critical SAP Enterprise Applications
- Lead the development, review, and maintenance of all GxP-critical documentation
- Collaborate directly with business users to finalize User Requirements Specifications (URS)
- Maintain the document repository for audit support
- Lead the change control process for all SAP system modifications
- Conduct thorough Impact Assessments for all proposed GxP system changes
- Participate in the Change Control Board (CCB) process
- Assist with the generation of change requests and lead the actual Change Execution in the system
- Prepare and maintain comprehensive Test Documentation
- Lead and perform the execution of validation testing and coordinate integration and system-level tests
- Act as the primary liaison between IT functional teams, Quality Assurance (QA), and key business process owners
Requirements
What you’ll need- 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.
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
SAP ERPSAP S/4HANAGxP Change ControlValidation executionGxP DocumentationSOPsWIsURSFSTest Scripts
Soft Skills
analytical skillsproblem-solving skillsattention to detaildocumentation accuracycommunication skillsinterpersonal skillscollaboration