SAP MM Functional & GxP

SAP S/4HANA Functional & GxP Consultant (Life Sciences / Pharma)

• Location: Santa Clara & SFO, preferred to be local to CA or near by region who can travel to the client location whenever required.
• Industry: Pharmaceuticals, Biotechnology, Medical Devices, Information Technology
• Experience Level: Mid-Senior level / Senior

ROLE OVERVIEW

• We are seeking an experienced SAP S/4HANA Functional & GxP Consultant to join our team. In this role, you will bridge the gap between IT capabilities and strict regulatory requirements. You will provide day-to-day production support and system optimization across core SAP modules while ensuring absolute compliance with Good Manufacturing Practices (GxP) and FDA regulations.
• If you possess a strong technical background in SAP supply chain modules paired with robust experience in life sciences validation, we want to hear from you.

Key Responsibilities

• SAP Production Support: Provide day-to-day troubleshooting and configuration support for SAP S/4HANA systems, specifically across Materials Management (MM), Quality Management (QM), Batch Management, and Manufacturing modules.
• System Optimization: Collaborate with business stakeholders to identify system enhancements, configure new functionalities, and improve overall supply chain and production operations.
• GxP Compliance & Validation: Ensure all SAP processes strictly comply with industry GxP regulations. Author, review, and execute GxP validation plans, protocols, and documentation.
• Quality & Batch Management: Support the integration of SAP QM processes (inspection lots, quality notifications, certificates) and manage Batch Management tracking for full traceability and compliance.
• Collaboration & Audits: Partner with QA, validation teams, and external vendors to conduct root-cause analysis for system issues. Assist in managing non-conformance and deviation processes, and support preparation for regulatory agency audits.
• Training & Master Data: Maintain accurate SAP master data (materials, vendors, QM) and create comprehensive user documentation and training materials for cross-functional teams.

Qualifications & Experience Required

• SAP Expertise: Strong hands-on experience configuring and supporting SAP S/4HANA modules (specifically MM and QM; Batch Management and Manufacturing experience is highly preferred).
• Life Sciences Regulation: Direct experience working within a regulated industry (Pharma, Biotech, or Medical Devices) with deep knowledge of GxP compliance guidelines and FDA standards (e.g., 21 CFR Part 11).
• Validation Background: Proven capability in executing validation protocols, creating validation master plans/reports, and managing deviation or change control processes within SAP.
• Communication Skills: Ability to collaborate seamlessly with IT teams, business users, QA engineers, and external regulatory auditors.