Deploy Sr Analyst MAKE QM
About the role
The Deploy Sr Analyst – Make Quality Management (QM) provides advanced hands-on expertise supporting the global deployment of Quality Management capabilities within the Transcend SAP S/4HANA program. From a Quality Management perspective, the role ensures full integration with NextGen QS to enable real-time control and disposition of non-conforming materials and batches across Source, Make, and Deliver. The role leads the end-to-end implementation of Quality processes supporting end-to-end release management, laboratory testing, manufacturing batch record review, and artwork (packaging material) key date management.
Global Batch Traceability is enabled through a single ERP backbone after full deployment, with the solution designed to support future integration of Global Batch Traceability (GBT) and Batch Record Hub (BRH). The role also leads the definition and deployment of batch determination rulesets, ensuring that only compliant and appropriate batches are used internally and released for shipment to customers across Make and Deliver.
Responsibilities
- Execute and support the global deployment of SAP Quality Management capabilities coordinated with NextGen QS, enabling real-time quality event handling and non-conformance management across Source, Make, and Deliver.
- Ensure standard satellite system integrations enabling end-to-end release management, laboratory testing, manufacturing batch record review, and artwork (packaging material) key date governance.
- Enable Global Batch Traceability through a single ERP backbone after full deployment and prepare the solution for future GBT and BRH integration.
- Define and govern batch determination rulesets ensuring compliant batch usage for internal operations and customer shipment.
- Act as senior functional authority supporting Quality Management functional SMEs and analysts, owning workload planning, prioritization, and delivery quality.
- Provide functional leadership and coaching while remaining hands-on to ensure solution quality and regulatory compliance.
- Act as the primary functional escalation point for QM-related topics within Transcend.
- Support solution confirmation with Global Template Owners, Quality Assurance, and Regulatory collaborators.
- Supervise functional testing, validation support, and hypercare activities for QM capabilities in alignment with GxP and CSV expectations.
- Ensure QM issues are resolved and lessons learned are incorporated into continuous improvement of the global template.
- Collaborate with Manufacturing, Supply Chain, Commercial Execution, IT, Validation, and Quality Assurance teams to ensure end-to-end quality integration.
- Partner with system integrators and satellite system owners to ensure compliant, auditable, and sustainable integrations.
Requirements
- University degree or equivalent experience in Quality, Engineering, Life Sciences, or a related field.
- A minimum of 3-5 years of proven experience.
- Extensive experience in Quality Management processes within GxP-regulated manufacturing environments.
- Strong functional expertise in SAP S/4HANA Quality Management (QM), including batch management, inspection processes, non-conformance handling, and release workflows.
- Confirmed experience leading or supporting SAP implementations subject to Computer System Validation (CSV) and regulatory inspection.
- Ability to travel up to 50% of the time both domestically and internationally.
Preferred Qualifications
- Experience integrating SAP QM with Quality satellite systems such as NextGen QS, LIMS, or electronic batch record platforms.
- Experience with Global Batch Traceability (GBT) and/or Batch Record Hub (BRH) concepts or implementations.
- Prior involvement in global ERP transformations within the Pharmaceutical or Life Sciences industry.
- Demonstrated experience supporting global process implementations, system deployments, and business transformation initiatives.
Skills
- Required Skills: Analytical Reasoning, Coaching, Communication, Cross-Functional Collaboration, Demand Forecasting, Human-Computer Interaction (HCI), Persistence and Tenacity, Product Costing, Product Development, Product Strategies, Quality Assurance (QA), Research and Development, Researching, Software Development Management, Technical Credibility, Technologically Savvy
- Preferred Skills: Agile Product Development, Collaboration, Competitive Landscape Analysis, Critical Thinking, Customer Alignment, Organizing, Product Improvements, Requirements Analysis, Software Development Life Cycle (SDLC), Stakeholder Management, Technical Writing
Pay
The anticipated base pay range for this position is $94,000 - $151,800.
Benefits
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits.