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Experienced Process Analyst – MAKE Quality Management (QM)
Johnson & Johnson. Execute and support global deployment of SAP Quality Management capabilities coordinated with NextGen QS .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in SAP S/4HANA Quality Management, including batch management and non-conformance handling, while ensuring compliance with GxP regulations. Proven ability to lead functional delivery and quality outcomes in a global manufacturing environment.
Highest-signal resume keywords
SAP S/4HANA Quality ManagementGxP ComplianceBatch ManagementComputer System ValidationQuality Management Processes
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ManagementBatch Determination RulesetsInspection ProcessesNon-Conformance HandlingRelease WorkflowsGlobal Batch TraceabilityLaboratory TestingManufacturing Batch Record ReviewArtwork Key-Date GovernanceFunctional Testing
Soft Skills
People ManagementWorkload PlanningPrioritizationCoachingCollaboration
Tools & Technologies
NextGen QSLIMSElectronic Batch Record PlatformsERP SystemsQuality Satellite Systems
Industry Keywords
Life SciencesPharmaceuticalRegulatory InspectionGlobal ERP TransformationsContinuous Improvement
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Execute and support global deployment of SAP Quality Management capabilities coordinated with NextGen QS
- Enable real-time quality event handling and non-conformance management across Source, Make, and Deliver
- Ensure standard satellite system integrations for end-to-end release management, laboratory testing, manufacturing batch record review, and artwork key-date governance
- Enable Global Batch Traceability through a single ERP backbone and prepare for future GBT and BRH integration
- Define and govern batch determination rulesets for compliant batch usage and customer shipment
- Act as senior functional authority for Quality Management SMEs and analysts
- Own workload planning, prioritization, and delivery quality
- Provide functional leadership and coaching while ensuring solution quality and regulatory compliance
- Serve as primary functional escalation point for QM topics within Transcend
- Support solution confirmation with Global Template Owners, Quality Assurance, and Regulatory collaborators
- Supervise functional testing, validation support, and hypercare activities aligned with GxP and CSV expectations
- Resolve QM issues and incorporate lessons learned into continuous improvement
- Collaborate with Manufacturing, Supply Chain, Commercial Execution, IT, Validation, and Quality Assurance teams
- Partner with system integrators and satellite system owners on compliant, auditable, and sustainable integrations
Requirements
What you’ll need- University degree or equivalent experience in Quality, Engineering, Life Sciences, or a related field
- Minimum 4 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
- Proven people-management experience with accountability for functional delivery and quality outcomes
- Preferred: Experience integrating SAP QM with Quality satellite systems such as NextGen QS, LIMS, or electronic batch record platforms
- Preferred: Experience with Global Batch Traceability (GBT) and/or Batch Record Hub (BRH) concepts or implementations
- Preferred: Prior involvement in global ERP transformations within the Pharmaceutical or Life Sciences industry
- Ability to travel up to 50% of the time domestically and internationally
Benefits
Comp & perks- Annual bonus with set target (% of pay) depending on pay grade/location, based on employee and company performance
- Vacation days
- Parental leave for a minimum of 12 weeks
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Well-being reimbursement
- Programs for financial, physical and mental health
- Service anniversary and recognition awards
- Insurance plans for employees and, in some locations, eligible dependents
- Netherlands annual base pay includes an 8% holiday allowance