GxP Digital QA Lead: AI/ML Validation & Compliance

Axiom Path, Inc.; Bridgewater (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Axiom Path, Inc. seeks a Senior Digital Systems Quality Assurance Engineer to validate GxP computerized systems and govern AI/ML compliance within a regulated biotech setting.

You will collaborate with IT, Digital Quality, and cross-functional teams to ensure patient safety and regulatory readiness. The role emphasizes risk-based validation, lifecycle documentation, and alignment with CSA, GAMP 5, Part 11, and Annex 11 standards.

Qualifications

• 7+ years of hands-on computerized system validation in FDA-regulated pharma/biotech environments.
• Bachelor's degree in Life Sciences, CS, Engineering, or related field; advanced degree preferred.
• Experience managing end-to-end GxP computerized system validation activities.

Responsibilities

• Lead and execute validation across enterprise GxP applications and clinical tech platforms.
• Develop validation documentation: URS, IQ/OQ/PQ, RTMs, VSRs.
• Apply FDA CSA, ISPE GAMP 5, EU Annex 11 requirements to validation efforts.
• Provide quality oversight for enterprise platforms like Veeva Vault and ServiceNow.
• Evaluate changes and qualification of SaaS, cloud, and on‑premise GxP apps.

Skills

Regulatory knowledge

Analytical thinking

Cross-functional collaboration

GxP validation

Education

Bachelors in Life Sciences/CS/Engineering

Tools

Veeva Vault Quality

Veeva RIM

Veeva Medical

ServiceNow

Qlik

Job description

Axiom Path, Inc. seeks a Senior Digital Systems Quality Assurance Engineer to validate GxP computerized systems and govern AI/ML compliance within a regulated biotech setting.

You will collaborate with IT, Digital Quality, and cross-functional teams to ensure patient safety and regulatory readiness. The role emphasizes risk-based validation, lifecycle documentation, and alignment with CSA, GAMP 5, Part 11, and Annex 11 standards.