Sumitomo Pharma America, Inc.

We are united in our mission to deliver patient-needed therapies sooner.

Manager, Enterprise Apps – Tech Ops

OperationsOperationsFull TimeRemoteTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

82 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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