Senior Business Analyst

We are seeking a highly experienced Senior Business Analyst with deep domain expertise in US pharmaceutical operations, drug manufacturing, and cell therapy lifecycle management within GxP-compliant environments. The ideal candidate will serve as a strategic bridge between business stakeholders and technology teams, driving digital transformation in regulated environments across MES, LIMS, QMS, ERP (SAP), and cloud platforms.

This role is critical to ensuring compliance with 21 CFR Part 11, GAMP5, and CSV (Computer System Validation) standards while enabling innovation in complex, patient-centric therapies such as cell and gene treatments.

Key Responsibilities

• Act as a primary liaison between manufacturing, quality, regulatory, R&D, supply chain, and digital health teams to gather, analyze, and translate business needs into actionable requirements.
• Lead end-to-end requirements elicitation thro...