4–8+ years of experience as a Business Analyst in pharma/biotech/life sciences
Strong understanding of non-conformance, deviation, and CAPA processes within GxP/GMP environments
Experience documenting BRDs/FRDs, user stories, and process maps (Visio, Lucidchart, etc.)
Strong stakeholder communication skills; ability to translate between business users and IT/system teams
Requirements:
Partner with QA and Compliance to capture and document requirements for non-conformances, deviations, and CAPAs
Translate business needs into functional requirements, process flows (current/future state), and user stories/acceptance criteria
Analyze and improve workflows across QMS, deviation/investigation processes, and batch record review/exception handling; facilitate cross-functional alignment with IT/system teams
Identify process gaps, compliance risks, and support data analysis and reporting on quality trends (NC volume, root cause, cycle time); assist with change management and user adoption
Job description
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
Qualifications
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)
Nice to Have
Exposure to regulatory inspections / audit readiness
Familiarity with data/reporting tools (Excel, Power BI, etc.)
