Associate Director, CSA & CSV — GxP Cloud Systems Leader

Nurix Therapeutics; Brisbane (CA); On-site; USD 190,000 - 217,000; Full time

Job summary

Nurix Therapeutics is seeking an Associate Director, Computer Systems Assurance (CSA) in Brisbane, CA to lead the GxP CSA program across Quality Systems, IT, Regulatory Affairs, and Clinical Operations. The role focuses on risk-based validation of SaaS and cloud-hosted platforms to ensure compliant, audit-ready systems.

Ideal candidates possess extensive CSV/GxP experience, familiarity with FDA/EMA expectations, and the ability to operate in a lean, virtual biotech environment, driving

Qualifications

• Bachelor's degree in computer science or related field.
• 7–10+ years in computer systems validation in GxP environments.
• Experience with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Proficiency validating SaaS/cloud platforms and vendor-managed models.

Responsibilities

• Own CSA policy framework and validation strategy; align with FDA CSA guidance and GxP requirements.
• Lead validation of GxP SaaS platforms (eQMS, electronic document management, RIM, LIMS).
• Create and review Validation Master Plans, URS, risk assessments, IQ/OQ/PQ, and traceability matrices.
• Coordinate validation testing with cross-functional teams and ensure fit-for-use test scripts.
• Review validation deliverables and maintain audit-ready validation files.

Skills

GxP knowledge

CSV expertise

Regulatory compliance

Validation leadership

Education

Bachelor's degree in computer science or related field

Tools

Veeva Vault

SaaS platforms

Cloud platforms

Job description

Nurix Therapeutics is seeking an Associate Director, Computer Systems Assurance (CSA) in Brisbane, CA to lead the GxP CSA program across Quality Systems, IT, Regulatory Affairs, and Clinical Operations. The role focuses on risk-based validation of SaaS and cloud-hosted platforms to ensure compliant, audit-ready systems.

Ideal candidates possess extensive CSV/GxP experience, familiarity with FDA/EMA expectations, and the ability to operate in a lean, virtual biotech environment, driving