Transcend: Deploy Make Qm Exp Analyst

Johnson & Johnson Johnson & Johnson · Pharma · Guaynabo, Puerto Rico +7

This role supports the global deployment of Quality Management (QM) capabilities within the Transcend SAP S/4HANA program. It ensures integration with NextGen QS for real-time control and disposition of non-conforming materials and batches across Source, Make, and Deliver. The role owns the end-to-end implementation of Quality processes for release management, laboratory testing, manufacturing batch record review, and artwork key date management. It also defines and deploys batch determination rulesets to ensure compliant batch usage and shipment. The role involves functional ownership, leadership, solution delivery, testing, hypercare, and cross-functional collaboration with various teams including IT, Validation, and Quality Assurance.

What you'd actually do

  1. Support the global deployment of SAP Quality Management capabilities integrated with NextGen QS, enabling real-time quality event handling and non-conformance management across Source, Make, and Deliver.
  2. Ensure standard satellite system integrations enabling end-to-end release management, laboratory testing, manufacturing batch record review, and artwork (packaging material) key date governance.
  3. Enable Global Batch Traceability through a single ERP backbone after full deployment and prepare the solution for future GBT and BRH integration.
  4. Define and govern batch determination rulesets ensuring compliant batch usage for internal operations and customer shipment.
  5. Participate in solution confirmation with Global Template Owners, Quality Assurance, and Regulatory stakeholders.

Skills

Required

  • University degree or equivalent experience in Quality, Engineering, Life Sciences, or a related discipline.
  • A minimum of four years professional experience
  • Experience with SAP Quality Management (QM) module
  • Understanding of GxP and CSV expectations
  • Experience in global deployment of enterprise systems
  • Strong collaboration and communication skills

Nice to have

  • Experience with NextGen QS
  • Knowledge of Global Batch Traceability (GBT) and Batch Record Hub (BRH)
  • Experience in pharmaceutical or healthcare industry

What the JD emphasized

  • GxP
  • CSV