Pharma BA: GxP, Validation & Digital Transformation

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

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.