Transcend Deployment Manager- MAKE Quality Management (QM)
PharmaMedTechRegulatory AffairsQuality Assuranceheoremacroraveinformsap
Job description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Digital Quality Job Category: Professional All Job Posting Locations: Latina, Italy, Leiden, Netherlands, Leiden, South Holland, Netherlands, Little Island, Cork, Ireland, Ringaskiddy, Cork, Ireland Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine . We are search for the best talent for Transcend Deployment Manager- MAKE Quality Managment (QM). This hybrid role is located in Cork, Ireland. Alternate hybrid locations may be considered at other Innovative Medicine Supply Chain (IMSC) hubs location such as: Latina, Italy; Madrid, Spain; and Leiden, Netherlands. Other J&J Innovative Medicine manufacturing / principal locations may be considered for the ideal candidate. Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one “clean” ERP as a standardized platform for growth and efficiency gains. The program will simplify the Innovative Medicine ERP landscape from 7 to 1, standardizing processes in order to have a cost effective, fit for purpose digital backbone that will enable us to support the Innovative Medicine business with agility. Additionally, the program will remediate the end-of-life system exposure that we risk towards the end of this decade. The Transcend Deployment Manager - Quality Management 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 is responsible for 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 developed to support future integration of Global Batch Traceability (GBT) and Batch Record Hub (BRH). The role also is responsible for 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. Key Responsibilities: Global Functional Ownership & Deployment Implement and 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. 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. Leadership & Team Management 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. Solution Delivery, Testing & Hypercare Support solution confirmation with Global Template Owners, Quality Assurance, and Regulatory collaborators. Lead 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. Cross-Functional Collaboration 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. Qualifications: Education University degree or equivalent experience in Quality, Engineering, Life Sciences, or a related field. Required A minimum 6 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. Validated experience leading or supporting SAP implementations subject to Computer System Validation (CSV) and regulatory inspection. Demonstrated people-management experience with accountability for functional delivery and quality outcomes. Experience in Supply Chain (Plan, Source, Make, Deliver, Finance and/or Master Data as well as Data and Analytics). Practical experience with ERP SAP Quality Management (QM) in J&J IM. Experience in Business Processes related to ERP SAP Quality Management (i.e. Quality Inspection, Batch Release, Supplier Qualification, Process Validations etc.). ERP SAP (ECC6 and/or S/4HANA) knowledge and practical application. Experience with Comet, eLIMS or Manufacturing Execution System (MES) is an advantage. S
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