The RM - SAP Batch Release Hub (BRH) SME will lead SAP BRH solution design and sustainment activities for Life Sciences clients, translating business, quality, manufacturing, and regulatory requirements into scalable and compliant end-to-end solutions. The role bridges hands-on production support, incident resolution, root cause analysis, and integration troubleshooting across SAP S/4HANA QM, LIMS, MES, and laboratory systems. Acting as a key technical authority, the SME will ensure strict compliance with Life Sciences regulatory standards while optimizing batch release cycle times and operational efficiency.
DAY-TO-DAY RESPONSIBILITIES
Lead SAP BRH sustainment, L2 production support, incident/ticket resolution (P1/P2), root cause analysis, defect management, and go-live/hypercare support.
Design, support, and troubleshoot integrations between SAP BRH, SAP S/4HANA, LIMS, MES, laboratory systems, and third-party middleware/APIs.
Partner with Quality, Manufacturing, Supply Chain, and IT stakeholders to define future-state processes, manage priorities, and align technical solutions with GxP regulatory expectations.
Ensure strict adherence to Life Sciences regulatory frameworks, including GMP/GxP, FDA regulations, 21 CFR Part 11, electronic signatures, audit trails, and validation documentation.
Conduct knowledge transition activities, root cause analysis, and continuous service improvements to enhance batch release workflows.
Collaborate with cross-functional architecture and program delivery teams to manage risk, evaluate vendor/resource needs, and execute release support for upcoming deployments.
REQUIRED SKILLS
SAP Batch Release Hub (BRH) implementation and sustainment experience (5+ years, minimum 2 engagements).
SAP S/4HANA Quality Management (QM) expertise including Batch Management, Inspection Lots, Usage Decisions, Quality Notifications, and Batch Disposition (8-10+ years).
Production Support & Sustainment Leadership, including P1/P2 Incident Management, Root Cause Analysis, and Hypercare (5+ years).
Hands-on experience with Life Sciences compliance standards (GMP/GxP, FDA 21 CFR Part 11, validation documentation, audit trails).
ADDITIONAL DESIRED SKILLS
SAP BTP / Integration Suite (3+ years, APIs/middleware support).
LIMS / MES Integration troubleshooting and support (3+ years).
Prior MedTech, Pharma, Biotech, or Pharmaceutical (Pharmaceutical) system environment experience.
Official SAP Certifications.
CANDIDATE PROFILE
The ideal candidate is a seasoned SAP Functional/Support Lead with a strong background in Life Sciences digital manufacturing and quality systems. They possess authoritative knowledge of SAP BRH and SAP S/4HANA QM, alongside a proven track record handling high-priority production incidents and complex GxP validation standards. They thrive in cross-functional client-facing roles, balancing technical troubleshooting with regulatory alignment and stakeholder management.
Job Responsibilities
Lead production support, P1/P2 incident resolution, root cause analysis, and defect management for SAP BRH and S/4HANA QM.
Troubleshoot and optimize integrations connecting SAP BRH with SAP S/4HANA, LIMS, MES, and laboratory systems.
Partner with cross-functional Quality, IT, and Supply Chain teams to align system processes with GxP and FDA 21 CFR Part 11 standards.
Facilitate knowledge transition, hypercare support, and continuous service improvements for upcoming release deployments.
Numbers & Facts
Location
Philadelphia, PA
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Skills
Application Programming Interface (API)unmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Bug Tracking/Defect Managementunmatched
Code of Federal Regulationsunmatched
Cross-Functionalunmatched
Customer Relationsunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
Functional Programming Languagesunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Identify Issuesunmatched
Incident Managementunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Systemsunmatched
Leadershipunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Execution Systems (MES)unmatched
Manufacturing Requirementsunmatched
Manufacturing Systemsunmatched
Middlewareunmatched
Production Supportunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Risk Analysisunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
SAPunmatched
Supply Chainunmatched
Validation Documentationunmatched
Vendor/Supplier Evaluationunmatched
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