SQA SME

Position Type: Contract – On-Site

About the Role

Join a certified technology solutions and compliance consulting services company as a Software Quality Assurance (SQA) Subject Matter Expert (SME). This role requires extensive validation experience and a strong understanding of GxP regulations and SDLC deliverables.

Responsibilities

• Ensure IT validation packages are inspection-ready and compliant with applicable company policies and procedures.
• Work autonomously with IT contacts and business process SMEs to maintain compliance.
• Support SQA review, approval, and implementation of regulated IT applications.
• Drive continuous improvement and provide input on validation strategies for IT changes.
• Collaborate with development teams to build compliance capabilities, ensuring deliverable quality and business needs are met.
• Review and approve SDLC deliverables (e.g., MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, System Release, and System Certification).
• Review CAPAs, Change Control, and Defects as they apply to software validation.
• Maintain compliance expertise and apply regulatory requirements in IT and business environments to support business goals.

Requirements

• 10+ years of strong validation experience in Software Quality Assurance.
• Experience in SDLC/Software Validation, including writing and executing deliverables (e.g., MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix).
• Proficient in GxP regulations and validation principles.
• Strong analytical skills with the ability to organize work logically and thoroughly.
• Highly self-motivated and self-directed.
• Understanding of risk management principles, regulatory requirements, and industry best practices.
• Knowledge of Waterfall and Agile software development methodologies.
• Previous experience with automated testing and implementation.
• Effective written and verbal communication skills in English, with the ability to provide regulatory guidance to project teams.

Skills

• Experience with tools such as JIRA, Confluence, Client-ALM, Tosca, Veera, Qtest, M-Files, and Microsoft Teams.
• Familiarity with Data Lake, AWS, Databricks, GitHub, or other continuous integration tools is a plus.