Manager, Enterprise Apps – Tech Ops
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $125,600 - $157,000 per year
Job Level
SeniorLead
Tech Stack
CloudSDLC
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SAP S/4HANASalesforce Health CloudAdvanced Therapy ManagementSystem Development Life CycleMaster Data ManagementGxP complianceChain of CustodyChain of IdentityGAMP 521 CFR Part 11
Soft skills
leadershipcommunicationproblem-solvingproject managementstrategic planning