Sumitomo Pharma America, Inc.
We are united in our mission to deliver patient-needed therapies sooner.
Manager, Enterprise Apps – Tech Ops
Location
North Carolina
Posted
83 days ago
Salary
$125.6K - $157K / year
Bachelor Degree8 yrs expEnglishCloudSDLC
Job Description
• Serve as the Solution Owner and functional expert for integrated systems
• Define the architecture, solution design, and technical roadmap for critical GxP systems
• Lead the integration strategy and execution between SAP S/4HANA, Salesforce ATM, and other GxP systems
• Translate complex business requirements related to Chain of Custody (CoC) and Chain of Identity (CoI) into compliant and scalable system solutions
• Own and enforce GxP compliance for all in-scope applications
• Directly manage the System Development Life Cycle (SDLC) for regulated systems
• Act as the primary point of contact during regulatory inspections and internal GxP audits
• Establish and govern processes for Master Data Quality and Governance
Job Requirements
- 8+ years of experience in implementing and managing enterprise systems within the Pharmaceutical, Biotech, or Cell/Gene Therapy industry
- Proven expertise in leading major transformation projects involving SAP S/4HANA (Sourcing, SC, QM, MM, SD modules)
- Direct, hands-on experience with Salesforce Health Cloud and/or Advanced Therapy Management (ATM)
- Deep practical knowledge of GxP regulations (21 CFR Part 11, GAMP 5, etc.)
- Strong understanding of Master Data Management (MDM) principles
- Specific knowledge of CGT processes, including CoC/CoI, apheresis, vector manufacturing, and final product distribution is highly desirable
- Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or a related field
Benefits
- Merit-based salary increases
- Short incentive plan participation
- Eligibility for 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
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