Business Analyst

Job Description: This position sits at the intersection of Data Quality, Regulatory Compliance, and Generative AI (Gen AI), driving digital transformation in GxP-regulated environments. The Business Analyst will collaborate closely with Quality, Data Science, and Technology teams to enhance AI-enabled quality processes, ensure data integrity, and foster compliant innovation. Key Responsibilities: - Partner with Quality, Regulatory, and Business stakeholders to gather and formalize requirements in line with Pharma GxP and compliance standards. - Translate business needs into validated requirements (URS/FRS), user stories, and acceptance criteria. - Drive initiatives focused on data integrity, data quality frameworks, and governance based on ALCOA+ principles. - Identify and define Gen AI use cases, such as deviation analysis, CAPA automation, document intelligence, and audit readiness. - Collaborate with Data Science and AI teams to define model inputs/outputs, validation and explainability requirements, and risk and compliance controls for AI solutions. - Facilitate workshops with cross-functional teams, including Quality Assurance (QA), IT, Data Engineering, and Regulatory Affairs. - Support computer system validation (CSV). - Develop and maintain documentation, including BRDs, FRS, traceability matrices, data lineage, data mapping artifacts, process flows, and SOP-aligned documentation. - Support UAT and validation cycles, ensuring solutions meet both business and regulatory expectations. - Act as a bridge between business, IT, and AI/analytics teams in a highly regulated environment. Required Skills & Qualifications: - 8+ years of experience as a Business Analyst in Life Sciences/Pharma environments. - Strong experience in Quality, data governance, and data quality management. - Proven exposure to GxP environments, regulatory compliance, and validation processes (CSV).