GxP IT Quality Assurance Lead

United Pharma; North Carolina; On-site; USD 115,000 - 150,000; Full time

Job summary

United Pharma is seeking an IT Quality Assurance Specialist / Lead in North Carolina to ensure GxP compliance for computerized systems across manufacturing. You will oversee CSV, data integrity, change control, deviations, CAPAs and supplier governance, while guiding teams in risk-based validation and quality processes.

The role collaborates with Quality, IT, Manufacturing, Engineering and Regulatory Affairs to maintain validated, inspection-ready systems and drive digital-transformation

Qualifications

• Bachelor’s or master’s degree in Computer Science, IT, Engineering, Pharmacy, Life Sciences or related discipline.
• 5–10 years of IT Quality Assurance, CSV or GxP IT compliance experience.
• Experience in regulated life-sciences manufacturing environments and audits.

Responsibilities

• Provide ITQA oversight for GxP computerized systems across manufacturing operations.
• Review validation deliverables (IQ/OQ/PQ, validation plans, traceability matrices).
• Assess changes, incidents, deviations, CAPAs and supplier governance for compliance.
• Support audits, inspections and evidence readiness.

Skills

IT Quality Assurance

Computer System Validation

GxP Compliance

Regulatory Audits

Documentation & QA Processes

Education

Bachelor’s or Master’s in CS/IT/Engineering/Pharma/Life Sciences

Tools

SAP

MES

LIMS

QMS

DMS

SCADA

BMS

EMS

Historians

Job description

United Pharma is seeking an IT Quality Assurance Specialist / Lead in North Carolina to ensure GxP compliance for computerized systems across manufacturing. You will oversee CSV, data integrity, change control, deviations, CAPAs and supplier governance, while guiding teams in risk-based validation and quality processes.

The role collaborates with Quality, IT, Manufacturing, Engineering and Regulatory Affairs to maintain validated, inspection-ready systems and drive digital-transformation