We are seeking an experienced Business Analyst with Pharma Domain expertise to bridge business and technology teams in delivering digital transformation, validation, data, and quality initiatives within regulated pharmaceutical environments.
The ideal candidate should have strong knowledge of pharmaceutical business processes, GxP regulations, and requirements management, with experience working across Manufacturing, Quality, Laboratory, Supply Chain, Validation, and IT functions.
Roles & Responsibilities:
Gather, analyze, and document business requirements from stakeholders.
Facilitate workshops, requirement elicitation sessions, and process mapping activities.
Translate business requirements into functional specifications, user stories, and acceptance criteria.
Collaborate with business SMEs, Quality, Manufacturing, Supply Chain, Validation, and IT teams.
Support Agile delivery teams in backlog refinement, sprint planning, and UAT activities.
Perform gap analysis and recommend process improvements.
Create and maintain business process flows (Visio), BRDs, FRDs, RTMs, and user stories.
Support validation activities in GxP-regulated environments.
Coordinate testing activities including SIT, UAT, and defect triage.
Ensure solutions comply with pharmaceutical regulations and quality standards.
Act as the liaison between business stakeholders and technical teams.
Experience:
5 10 years of experience as a Business Analyst in the Pharmaceutical domain.
Strong understanding of pharmaceutical business processes.
Experience working in GxP-regulated environments.
Knowledge of 21 CFR Part 11, GAMP 5, Good Documentation Practices (GDP), Change Control, CAPA, Deviations, and Validation Lifecycle (CSV).
Experience in requirements gathering and analysis, business process mapping, gap analysis, user story creation, stakeholder management, BRD, FRD, RTM documentation, and UAT planning and execution.
Proficiency with JIRA, Confluence, MS Visio, Microsoft Office Suite, and Client ALM/AQM (Good to Have).
Experience handling AI projects is a plus.
Numbers & Facts
Location
Aguadilla, PR
Skills
Acceptance Testingunmatched
Agile Programming Methodologiesunmatched
Artificial Intelligence (AI)unmatched
Atlassian JIRAunmatched
Backlog Prioritizationunmatched
Biotech and Pharmaceuticalunmatched
Bug Tracking/Defect Managementunmatched
Business Analysisunmatched
Business Processesunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Documentationunmatched
Documentation Planunmatched
Functional Requirements Document (FRD)unmatched
Gap Analysisunmatched
GxPunmatched
Manufacturingunmatched
Microsoft Officeunmatched
Microsoft Visiounmatched
Pharmaceutical Analysisunmatched
Process Flowunmatched
Process Improvementunmatched
Quality Assuranceunmatched
Quality Metricsunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Requirements Managementunmatched
Sprint Planningunmatched
Supply Chainunmatched
Technical Deliveryunmatched
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