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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.

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.

This program will simplify the Pharmaceutical ERP landscape from 7 to 1, standardizing processes to have a cost-effective, fit-for-purpose digital backbone that will enable us to support the Pharmaceutical business with agility.

Additionally, the program will remediate the end-of-life system exposure that we risk towards the end of this decade.

We are seeking a Transcend Deploy Sr Analyst MAKE QM .

Role Purpose

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.

Global Functional Ownership & Deployment

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.

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.
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.
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 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.

Preferred:

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.

Other:

Ability to travel up to 50% of the time both domestically and internationally.

Preferred 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

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