Business Analyst (Pharma)

Job Role: Business Analyst -Pharma.

Location: USA - Remote

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 candidate should possess strong knowledge of pharmaceutical business processes, GxP regulations, and requirements management, with experience working across manufacturing, quality, laboratory, supply chain, and IT functions.

Key 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.

Must-Have Skills

Pharma Domain

Strong understanding of pharmaceutical business processes.

Experience  working in regulated environments (GxP).

Knowledge  of:

21 CFR Part 11

GAMP 5

Good Documentation Practices (GDP)

Change Control, CAPA, Deviations

Validation Lifecycle (CSV)

Good to Have

Experience in handling AI project .

Business Analysis

Requirements Gathering & Analysis

Business Process Mapping

Gap Analysis

User Story Creation

Stakeholder Management

Documentation (BRD, FRD, RTM)

UAT Planning and Execution

Tools

JIRA

Confluence

MS Visio

HP ALM  / AQM (Good to Have)

Microsoft Office Suite