Job Details

Business Analyst - Non-Conformance (Pharma / QA Systems)
Overview
We are seeking a Business Analyst to support a pharmaceutical quality organization focused on non-conformance (NC), deviations, and CAPA processes. This individual will work cross-functionally with Quality, and IT to improve processes, systems, and reporting tied to quality events.
This is a process-heavy, stakeholder-facing role, less technical build, more translation, structure, and execution.
Key Responsibilities

• Partner with Quality Assurance (QA), and Compliance teams to gather and document requirements related to:
  • Non-conformances (Company)
  • Deviations
  • CAPAs (Corrective & Preventive Actions)
• Translate business needs into:
  • Functional requirements
  • Process flows (current state / future state)
  • User stories / acceptance criteria
• Analyze and improve workflows across:
  • Quality Management Systems (QMS)
  • Deviation and investigation processes
  • Batch record review / exception handling
  • Facilitate cross-functional meetings and ensure alignment between:
    • QA
    • IT / system teams
  • Identify process gaps, inefficiencies, and compliance risks
  • Support data analysis and reporting on quality trends (NC volume, root cause, cycle time)
  • Assist with change management and user adoption

• 4-8+ years of experience as a Business Analyst in pharma / biotech / life sciences
• Strong understanding of:
  • Non-conformance / deviation / CAPA processes
  • GxP / GMP environments
• Ability to translate between business users and technical teams
• Experience documenting:
  • BRDs / FRDs / user stories
  • Process maps (Visio, Lucidchart, etc.)
• Strong stakeholder communication skills (this is key)

• Exposure to regulatory inspections / audit readiness
• Familiarity with data/reporting tools (Excel, Power BI, etc.)