Source Code Technologies LLC

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Business Analyst – Pharma/GxP/Data Governance/Gen AI Location: Remote Experience: 8+ Years Domain: Pharma / Life Sciences Job Description We are seeking an experienced Business Analyst with strong Pharma/Life Sciences domain expertise to support initiatives focused on Data Quality, Regulatory Compliance, and Generative AI (Gen AI) within GxP-regulated environments. The ideal candidate will work closely with Quality, Regulatory, Data Science, and Technology teams to drive compliant digital transformation and AI-enabled quality processes. Key Responsibilities • Collaborate with Quality, Regulatory, and business stakeholders to gather, analyze, and document business and system requirements aligned with Pharma GxP standards. • Translate business requirements into BRDs, FRDs, URS/FRS documents, user stories, and acceptance criteria. • Drive initiatives related to data governance, data integrity, and data quality management based on ALCOA+ principles. • Identify and support Gen AI use cases including deviation analysis, CAPA automation, audit readiness, and document intelligence. • Partner with Data Science and AI teams to define model inputs/outputs, validation requirements, explainability standards, and compliance controls. • Facilitate workshops and discussions with cross-functional teams including QA, Regulatory Affairs, IT, Data Engineering, and Analytics. • Support Computer System Validation (CSV) activities and ensure compliance with regulatory requirements. • Develop and maintain traceability matrices, process flows, SOP-aligned documentation, data lineage, and mapping documents. • Coordinate and support UAT, validation cycles, and defect management activities. • Act as a liaison between business stakeholders, technical teams, and AI/analytics teams in a regulated environment. Required Qualifications • 8+ years of experience as a Business Analyst in Pharma or Life Sciences environments. • Strong understanding of GxP, FDA regulations, CSV, and validation processes. • Experience in Quality Management, Data Governance, and Data Quality initiatives. • Hands-on experience with BRD, FRD, URS, FRS, RTM, and UAT documentation. • Knowledge of ALCOA+ principles and data integrity frameworks. • Experience working with cross-functional teams in regulated environments. • Excellent communication, stakeholder management, and analytical skills. • Exposure to AI/Gen AI projects in Pharma or regulated domains is highly preferred. Preferred Skills • Experience with Quality systems, CAPA, deviations, and audit processes. • Familiarity with Agile/Scrum methodologies. • Understanding of AI governance, risk, and compliance frameworks. • Experience with pharma data platforms and analytics initiatives.