Senior Software Quality Assurance (SQA) SME

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. Key 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. Required Skills 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. #J-18808-Ljbffr QvalFocus Inc.