Business Analyst

Source Code Technologies LLC is a company focused on driving digital transformation in GxP-regulated environments. The Business Analyst will work at the intersection of Data Quality, Regulatory Compliance, and Generative AI, collaborating with various teams to enhance AI-enabled quality processes and ensure data integrity.

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

Requirements:

• 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)