Senior GxP Business Analyst

Job Summary We are seeking a Senior Business Analyst with experience in Quality, Clinical, and Regulatory domains within the pharmaceutical or biotech industry. The ideal candidate will gather business requirements, create functional and data specifications, support data mapping, collaborate with technical teams, and coordinate testing activities in a GxP-regulated environment. Key Responsibilities • Gather and analyze business, Quality, Clinical, and Regulatory requirements. • Create functional requirements, user stories, and data mapping documents. • Work with business stakeholders, data engineers, and validation teams to deliver data solutions. • Support Agile projects by managing scope, requirements, and user feedback. • Coordinate UAT and validation activities to ensure business requirements are met. • Support data governance, metadata management, and data quality initiatives. Required Skills • 5+ years of Business Analysis experience in pharmaceutical or biotech industries. • Experience with GxP, 21 CFR Part 11, Quality, Regulatory, and Clinical systems. • Strong SQL and data analysis skills. • Experience with Veeva Vault, Snowflake, Power BI, Oracle, JIRA, and ALM. • Knowledge of Agile methodologies, data mapping, and testing/validation. • Excellent communication and stakeholder management skills.