Senior Software QA & Validation Lead (SDLC/GxP)

United Pharma; Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma seeks a Software QA professional with SDLC validation experience to lead review and approval of regulated IT deliverables. The role focuses on MVPs, risk assessments, IQ/OQ/PQ, trace matrices, and system release with emphasis on CAPA, change control, and defect management in a compliant GMP/GLP context.

The candidate should excel in collaboration with development teams, ensuring continuous improvement of validation strategies and clear regulatory guidance across projects.

Qualifications

• Experience validating SDLC deliverables (MVP, Risk Assessment/FMEA, Requirements, IQ, OQ, PQ, Trace Matrix, System Release)
• Review and approve SDLC deliverables and CAPAs/Change Controls/Defects as they apply to software validation
• Strong understanding of GxP regulations and validation principles
• Experience with automated testing and CI tools is a plus
• Excellent written and verbal English communication in regulated environments

Responsibilities

• Ensure IT validation packages are inspection ready and compliant with company policies
• Lead in Review and Approval of regulated IT applications
• Collaborate with development teams to build compliance capabilities for high-quality deliverables
• Support validation strategy for IT changes and process improvements
• Communicate regulatory guidance to project teams

Skills

SDLC validation

Regulatory compliance

Analytical thinking

Effective communication

Risk management

Tools

JIRA

Confluence

HPALM

Tosca

Qtest

MFiles

Job description

United Pharma seeks a Software QA professional with SDLC validation experience to lead review and approval of regulated IT deliverables. The role focuses on MVPs, risk assessments, IQ/OQ/PQ, trace matrices, and system release with emphasis on CAPA, change control, and defect management in a compliant GMP/GLP context.

The candidate should excel in collaboration with development teams, ensuring continuous improvement of validation strategies and clear regulatory guidance across projects.