Senior Software Quality Assurance (SQA) SME

Location: Lake Forest, IL • Duration: 12 Months

About the role

Our client is seeking a Senior SQA SME with 10+ years of experience in Software Quality Assurance, Software Validation, and regulated IT environments. The ideal candidate will have strong experience reviewing and approving SDLC/validation deliverables and ensuring compliance with GxP requirements.

Responsibilities

• Review and approve SDLC and software validation deliverables, including MVP, FMEA/Risk Assessment, Requirements, IQ/OQ/PQ, Traceability Matrix, and System Release/Certification.
• Review CAPAs, Change Controls, Defects, and deviations related to software validation.
• Ensure validation packages are compliant, complete, and inspection-ready.
• Provide SQA and regulatory guidance to IT, development, QA, and business teams.
• Support validation strategy, continuous improvement, and regulated IT application implementation.
• Work effectively across Agile and Waterfall environments.

Requirements

• 10+ years of SQA/Software Validation experience.
• Strong knowledge of GxP, CSV/CSA, SDLC, and validation principles.
• Hands-on experience with software validation documentation and SQA review/approval.
• Experience with automated testing and risk management.
• Strong communication and stakeholder management skills.
• Experience with JIRA, Confluence, HP ALM, Tosca, qTest, M-Files, or Veeva.
• Knowledge of AWS, Databricks, GitHub, Data Lakes, or CI/CD tools is a plus.