Business Analyst (w2 only)

Introduction:

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.

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:

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).

Preferred Skills:

• User Stories
• Generative Artificial Intelligence (AI)
• Acceptance Testing
• Analytics
• Artificial Intelligence
• Auditing
• Collaboration
• Computerized System Validation
• Corrective And Preventive Action
• Data Engineering
• Data Governance
• Data Integrity
• Data Mapping
• Data Quality
• Data Science
• Documentation
• FRS
• GxP
• Innovation
• Life Sciences
• Pharmaceutics
• Process Flow
• Quality Assurance
• Regulatory Affairs
• Regulatory Compliance
• SOP
• Traceability Matrix
• URS
• Use Cases