Business Analyst

Katalyst CRO; Aguadilla (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Katalyst CRO is 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 across Manufacturing, Quality, Laboratory, Supply Chain, Validation, and IT functions.

Qualifications

• Knowledge of pharmaceutical business processes and GxP regulations.
• Experience with requirements management across multiple functions.
• Experience facilitating workshops and elicitation sessions.

Responsibilities

• Gather and document business requirements from stakeholders.
• Facilitate workshops and process-mapping activities.
• Translate requirements into functional specs, user stories, and acceptance criteria.
• Collaborate with business SMEs, Quality, Manufacturing, and IT.
• Support Agile delivery teams in backlog refinement and UAT.

Skills

Pharma domain knowledge

GxP regulations

Requirements management

Agile / backlog grooming

Stakeholder management

Tools

JIRA

Confluence

MS Visio

MS Office

ALM/AQM

Job description

• 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.
• 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.

Job Summary

• 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:

• 510 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.