Senior SQA Expert: GxP & Validation Lead

QvalFocus Inc.

Lake Forest (IL)

On-site

USD 120,000 - 180,000

Full time

2 days ago
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Job summary

QvalFocus Inc. in Lake Forest, IL seeks a Senior SQA SME with 10+ years of experience in software quality assurance, validation, and regulated IT environments. The role focuses on reviewing and approving SDLC/validation deliverables and ensuring GxP compliance.

You will provide SQA guidance across IT, development, QA, and business teams, support validation strategy, and work across Agile and Waterfall projects. Strong communication and documentation skills are essential.

Qualifications

  • 10+ years of SQA/Software Validation experience.

Responsibilities

  • Review and approve SDLC and software validation deliverables, including MVP, FMEA/Risk Assessment, Requirements, IQ/OQ/PQ, Traceability Matrix, and System Release/Certification.

Skills

SQA/Software Validation
GxP Compliance
Regulated IT
SDLC/Validation Deliverables
CAPA & Change Control
Regulatory Documentation
Stakeholder Management
Agile & Waterfall

Tools

JIRA
Confluence
HP ALM
Tosca
qTest
M-Files
Veeva

Job description

QvalFocus Inc. in Lake Forest, IL seeks a Senior SQA SME with 10+ years of experience in software quality assurance, validation, and regulated IT environments. The role focuses on reviewing and approving SDLC/validation deliverables and ensuring GxP compliance.

You will provide SQA guidance across IT, development, QA, and business teams, support validation strategy, and work across Agile and Waterfall projects. Strong communication and documentation skills are essential.

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