Company Profile: Quantum Integrators is an international strategy and business consulting group whose mission is to help clients create and sustain competitive advantage. As a truly client-focused firm, our highly trained and experienced consultants consider it their mandate to help client organizations achieve a 'quantum state.
Position: SAP QM Batch Release Hub Functional Configuration Lead
Location: Beerse, Belgium (Onsite)
Duration: Fulltime with Quantum Integrators / Quanta Systems Technologies LLP
Job Description:
* The Batch Release Hub Functional Configuration Lead serves as the primary business-facing SAP solution expert for the Batch Release Hub (BRH) within J&J's SAP SAS (Serialization & Aggregation System) platform.
* This role bridges Quality Assurance, Regulatory Affairs, Manufacturing, and Supply Chain Operations with SAP S/4HANA capabilities to define, configure, and sustain best-in-class batch disposition and release processes across J&J's global pharmaceutical and consumer health supply chain.
Required Qualification:
* Education: Bachelor's degree in Pharmacy, Life Sciences, Engineering, Supply Chain, or a related field. Advanced degree preferred.
* Experience: 7+ years in SAP functional roles within life sciences or pharmaceutical manufacturing, with at least 3 years focused on SAP QM and batch management processes.
* SAP QM Expertise: Deep functional knowledge of SAP QM module including inspection lots, usage decisions, defect recording, quality notifications, and certificates of analysis.
* Batch Release Domain: Strong understanding of pharmaceutical batch release processes, GMP requirements, and the relationship between QA systems, LIMS, and ERP in a regulated environment.
* GxP & Regulatory: Practical knowledge of FDA 21 CFR Part 11, EU Annex 11, ICH Q10, and site-level GMP compliance requirements as they relate to ERP batch management.
* Stakeholder Management: Proven ability to work with cross-functional teams including QA, Manufacturing, Regulatory, and Supply Chain in a global matrix organization.
* Process Design: Experience documenting functional specifications, PDD/URS documents, and process flow diagrams using tools such as Visio, Lucidchart, or equivalent.
Key Responsibilities:
* Act as the functional owner of end-to-end batch release processes within SAP BRH, including batch disposition, usage decisions, batch status transitions, and certificate of analysis (CoA) generation.
* Translate business and regulatory requirements from QA, Regulatory Affairs, and Manufacturing into SAP functional specifications and solution designs.
* Configure and maintain SAP QM inspection types, inspection plans, master inspection characteristics (MICs), sampling procedures, and quality info records aligned to BRH workflows.
* Define and configure batch classification schemas, batch characteristics hierarchies, and usage decision codes to support global release standards.
* Lead functional design workshops, process walkthroughs, and fit-gap analyses with J&J business stakeholders across sites and regions.
* Author and review functional specifications, process design documents (PDDs), and user requirement specifications (URS) for BRH enhancements and projects.
* Support GxP validation activities including UAT test script development, defect triage, and sign-off activities in partnership with QA and CSV teams.
* Collaborate with the technical configuration team to ensure alignment between functional design and SAP system configuration.
* Define and support training materials, SOPs, work instructions, and change management activities for BRH process rollouts.
* Manage functional escalations, Tier 2/3 production support issues, and change requests related to BRH processes.
* Serve as a liaison between J&J Quality Systems, Supply Chain, and IT to drive continuous process improvement on the BRH platform.
* Support regulatory inspections and audits by providing system process evidence, audit trails, and electronic records documentation.
Preferred Qualification:
* Experience with SAP SAS (Serialization & Aggregation System) or SAP ATTP in a pharmaceutical environment.
* SAP Certified Application Associate – SAP S/4HANA Quality Management or Supply Chain Management.
* Prior experience in a global life sciences company with multiple manufacturing sites and complex supply chains.
* Familiarity with LIMS platforms (LabWare, BIOVIA) and their integration touchpoints with SAP QM for batch release.
* Knowledge of SAP Batch Where-Used reporting and supply chain traceability for pharmaceutical products.
* Experience with Agile/SAFe methodologies and enterprise IT delivery in large-scale transformation programs.
* Exposure to J&J ONE ERP or other J&J enterprise systems and global quality management frameworks.
Core Functional Competencies:
* SAP QM Processes: Inspection lots, usage decisions, MICs, sampling schemes, quality notifications, CoA management
* Batch Management: Batch classification, batch status, batch determination, shelf life management, FEFO/FIFO
* Regulatory Compliance: GMP, GDP, 21 CFR Part 11, EU Annex 11, ICH Q10, audit trail requirements
* Process Documentation: URS, PDD, FS authoring; SOP and work instruction development
* Delivery Tools: JIRA, Confluence, MS Visio, Agile/SAFe, SAP Activate
Company’s Website: https://www.quantumintegrators.com/
Company’s LinkedIn Profile: https://www.linkedin.com/company/quantum-integrators-group-llc/