Business Analyst

Job Summary

We are seeking an experienced Business Analyst (BA) with a strong background in Life Sciences / Biopharma / Drug Manufacturing and proven experience working with IT teams to translate business needs into clear functional and technical requirements.

The ideal candidate will act as a bridge between business stakeholders (Manufacturing, QA, R&D) and IT teams, ensuring solutions align with regulatory requirements and business objectives in a GxP-compliant environment.

Key Responsibilities

Business & Domain Analysis

• Collaborate with stakeholders across Manufacturing, Quality, Supply Chain, and R&D to understand business processes and challenges
• Analyze and document workflows related to:
• Drug manufacturing (batch processes, MES, LIMS)
• Quality processes (Deviation, CAPA, Change Control)
• Ensure all requirements comply with GxP, FDA, and regulatory standards

Requirement Gathering & Documentation

• Elicit, analyze, and document requirements using:
• BRD (Business Requirement Documents)
• FRD (Functional Requirement Documents)
• User stories and acceptance criteria
• Create process flows, use cases, and data flow diagrams
• Perform gap analysis and impact assessment

Business to IT Translation

• Translate business requirements into:
• Functional specifications
• Technical requirements (in collaboration with architects/dev teams)
• Define system behavior, integration points, and data requirements
• Support design discussions with technical teams and solution architects

Technology & Integration Support

• Work closely with IT teams on:
• APIs (REST/SOAP), system integrations, middleware
• Enterprise systems (e.g., SAP, MES, LIMS, Veeva, TrackWise)
• Document:
• Interface specifications
• Data mapping and transformation logic

Testing & Validation

• Support UAT planning and execution
• Develop test scenarios, test cases, and traceability matrices (RTM)
• Ensure systems meet compliance and validation requirements (CSV/CSA)
• Participate in audits and validation documentation (URS, IQ/OQ/PQ)

Stakeholder Management

• Act as a liaison between:
• Business users (non-technical)
• IT and development teams
• Facilitate workshops, requirement sessions, and solution reviews
• Communicate complex technical concepts in a simple, business-friendly manner

Required Qualifications

Education

• Bachelor’s or Master’s degree in:
• Life Sciences / Pharmacy / Biotechnology
• Computer Science / Engineering (with domain experience)

Experience

• 5+ years of experience as a Business Analyst
• Strong experience in Life Sciences / Biopharma / Pharma manufacturing domain
• Proven experience working with IT delivery teams

Domain Knowledge

• Understanding of:
• Drug manufacturing processes
• GxP (GMP, GCP, GLP) environments
• Regulatory frameworks (FDA, EMA, 21 CFR Part 11)
• Familiarity with:
• QMS systems (Deviation, CAPA, Change Control)
• Validation processes (CSV / CSA)

Technical Skills

• Good understanding of:
• APIs, integrations, and system architectures
• Data modeling and basic SQL concepts
• Experience with enterprise systems:
• SAP, MES (e.g., Werum PAS-X), LIMS, Veeva, TrackWise
• Tools:
• JIRA / Azure DevOps
• Confluence
• Visio / Lucidchart

Core BA Skills

• Strong requirement elicitation and documentation skills
• Experience with Agile and/or Waterfall methodologies
• Ability to create:
• Process flows (BPMN/UML)
• Functional specifications
• User stories and acceptance criteria

Preferred Qualifications

• Experience in serialization / track & trace (DSCSA, EU FMD)
• Exposure to cloud platforms (Azure / AWS)
• Knowledge of pharmacovigilance or clinical systems
• BA certifications (CBAP, PMI-PBA)

Key Competencies

• Strong analytical and problem-solving skills
• Excellent communication and stakeholder management
• Ability to bridge business and technical teams effectively
• Attention to detail in regulated environments
• Adaptability in fast-paced project environments