Product Owner, SAP Manufacturing Systems

Responsibilities

• Serve as the SAP solution architect for cell therapy manufacturing processes across SAP modules (PP-PI, QM, MM, WM/EWM), ensuring compliance with GMP/GxP and 21 CFR Part 11
• Oversee SAP configuration and development efforts, ensuring scalability and traceability for both clinical and commercial advanced therapies
• Collaborate closely with Manufacturing, Quality, IT, Regulatory, and Clinical Operations to define business requirements and translate them into validated SAP functionality
• Drive integration with adjacent systems such as MES (e.g., Tulip, Werum PAS-X), LIMS, serialization platforms (SAP ATTP), patient scheduling, and cold chain logistics
• Provide leadership for system validation, audit readiness, SOP development, and change management in alignment with GMP and global regulatory frameworks (FDA, EMA, ICH)
• Act as SME in internal audits, regulatory inspections, and quality system assessments for digital manufacturing systems
• Support continuous improvement initiatives within the digital supply chain and IT/OT domains

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Information Systems, or related field
• 8+ years of hands-on experience with SAP in life sciences, including 5+ years focused on manufacturing or supply chain in GMP-regulated environments
• Proven expertise in SAP PP-PI, QM, MM, and integration with production execution and serialization systems
• Deep understanding of cell therapy manufacturing operations, including autologous/allogeneic workflows, scheduling, and chain-of-identity controls
• Experience working in validated environments under GAMP5, Annex 11, 21 CFR Part 11, and data integrity expectations
• Demonstrated success in system design and delivery for personalized or batch-level therapies
• Experience with SAP S/4HANA, including advanced planning (PP-DS), ATTP, or EWM
• Familiarity with cell therapy scheduling platforms, clinical supply chain integration, or patient engagement platforms
• Experience in greenfield SAP implementations or digital transformation initiatives in biopharma
• SAP certification is a plus
• Experience with Agile or hybrid project methodologies
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset