Business Analyst – Pharma/GxP/Data Governance/Gen AI
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.
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