SAP Batch Release Hub SME

• Lead SAP Batch Release Hub (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.
• Demonstrate strong expertise in SAP BRH, SAP S/4HANA QM, batch management, inspection lots, usage decisions, quality notifications, batch disposition, and release decision workflows across pharmaceutical and regulated manufacturing environments.
• Must have hands-on SAP BRH sustainment/support experience, including production support, incident and ticket resolution, root cause analysis, defect management, integration troubleshooting, release support, and continuous service improvements.
• Design, support, and troubleshoot integrations between SAP BRH, SAP S/4HANA, LIMS, MES, laboratory systems, and third-party applications, ensuring data integrity and seamless batch release execution. Partner with Quality, Manufacturing, Supply Chain, and IT stakeholders to gather requirements, facilitate workshops, define future-state processes, manage priorities, and align solutions with business objectives and regulatory expectations.
• Ensure compliance with Life Sciences regulatory requirements, including GMP/GxP, FDA regulations, 21 CFR Part 11, electronic signatures, audit trails, validation documentation, and inspection-readiness standards. Collaborate with cross-functional architecture, delivery, and business teams to identify risks, develop mitigation strategies, support enhancements, and drive key solution and program decisions impacting multiple workstreams.
• Serve as a SAP BRH subject matter expert, providing leadership, mentoring team members, supporting vendor/resource evaluations, and delivering business-value-driven solutions that improve batch release cycle times, compliance, and operational efficiency.

• Preferred Skills Prior SAP BRH implementation and sustainment experience.
• SAP S/4HANA QM and Life Sciences background. Experience with SAP BTP, Integration Suite, APIs, LIMS, and MES integrations.
• Pharmaceutical, biotech, medical device, or Client experience strongly preferred.

Must-Have Skills & Experience:

SAP Batch Release Hub (BRH) Implementation & Support:

• Minimum 2 SAP BRH implementation and/or sustainment engagements
• Hands-on experience supporting BRH in production environments
• 5+ years relevant experience

SAP S/4HANA Quality Management (QM):

• 8-10+ years’ experience
• Batch Management
• Inspection Lots
• Usage Decisions
• Quality Notifications
• Batch Release and Disposition Processes

Production Support & Sustainment Leadership:

• 5+ years’ experience
• Incident Management
• P1/P2 Ticket Resolution
• Root Cause Analysis
• Defect Remediation
• Hypercare and Go-Live Support
• Knowledge Transition Activities

Nice-to-Have Skills:

SAP BTP / Integration Suite:

• APIs and middleware support

LIMS / MES Integrations:

• Integration troubleshooting and support

Life Sciences Digital Manufacturing Platforms:

• Prior MedTech, Pharma, Biotech
• SAP validation and compliance environments, * Bachelor’s degree in information systems, Computer Science, Engineering, Supply Chain, Life Sciences, or related discipline.
• Master’s degree preferred but not required.
• SAP Certifications are desirable.

Industry Experience Needed: Yes. Strongly Preferred.

Reason:

• Resource will support SAP BRH in a regulated Life Sciences environment.
• Must understand GMP/GxP, FDA regulations, 21 CFR Part 11, validation documentation, audit readiness, and batch release processes.
• Pharma, MedTech, Biotechnology, and experience are highly desirable.

Key Skills: SAP BRH, QM, S4HANA, Life Science