Transcend Deploy Make QM Exp Analyst
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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:
Technology Product & Platform ManagementJob Sub Function:
Technical Product ManagementJob Category:
Scientific/TechnologyAll Job Posting Locations:
Beerse Antwerp BelgiumJob Description:
Deploy ExperiencedAnalyst Make Quality Management (QM)
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.
About Transcend
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 Pharmaceutical ERP landscape from seven systems to one standardizing processes to create a cost-effective fit-for-purpose digital backbone that enables agility and scalability across the business. Additionally Transcend will remediate end-of-life system exposure expected toward the end of this decade reducing risk while enabling long-term sustainability.
Role Purpose
The Functional Deployment Lead 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 owns 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 owns 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 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 stakeholders.
Oversee 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.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.
While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):
United States - Requisition Number: R-066659
Belgium - Requisition Number:
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
#LI-Hybrid
Qualifications Required
A minimum two years professional experience
University degree or equivalent experience in Quality Engineering Life Sciences or a related discipline.
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.
Proven 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.
Qualifications 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.
Other:
Ability to travel up to 50% of the time both domestically and internationally.
Required Skills:
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 SavvyRequired Experience:
IC
Key Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more