SQA SME

Position Type: Contract – onsite

About the Role

A certified technology solutions and compliance consulting services company is seeking a Senior SQA Subject Matter Expert with 10+ years of experience in system validation, GxP regulations, and software quality assurance.

Responsibilities

• Ensure IT validation packages are inspection-ready and compliant with 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.
• Maintain compliance expertise and apply regulatory requirements in IT and business environments to support business goals.

Requirements

• 10+ years of experience in software quality assurance and system validation.
• Proficient in GxP regulations, validation principles, and risk management.
• Strong analytical skills with the ability to organize work logically and thoroughly.
• Highly self-motivated and self-directed.
• Understanding of Waterfall and Agile software development methodologies.
• Experience with automated testing and implementation.
• Familiarity with tools such as JIRA, Confluence, HP-ALM, Tosca, Veera, Qtest, M-Files, Microsoft Teams, Data Lake, AWS, Databricks, GitHub, or other CI/CD tools.
• Effective written and verbal communication skills in English, providing regulatory guidance to project teams.

Qualifications

• Experience in SDLC/software validation, including writing and executing deliverables (e.g., MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, System Release).
• Experience reviewing CAPAs, change controls, and defects as they relate to software validation.
• Strong soft skills, including effective communication and active participation in meetings and projects.