Strategic CSA Lead: Associate Director

BioSpace; Brisbane (CA); On-site; USD 171,000 - 216,000; Full time

Job summary

Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager/Associate Director to lead Computer Systems Assurance across QA, IT, and Regulatory. You will own CSA policy, risk-based validation for SaaS/gxP systems, and drive compliance with FDA/ICH guidance, Annex 11, and GAMP 5.

You will partner with Quality, IT, Regulatory Affairs, and Clinical Ops to assure data integrity, change control, and inspection readiness in a lean, virtual biotech environment.

Qualifications

• Bachelor's degree in computer science, life sciences, or related field.
• Demonstrated knowledge of FDA Part 11, EU Annex 11, and GAMP 5 guidelines.
• Experience validating SaaS/cloud GxP platforms.

Responsibilities

• Own and advance Nurix's CSA program and validation strategy.
• Lead validation activities for GxP SaaS platforms and maintenance.
• Coordinate testing with cross-functional teams and review deliverables.
• Support regulatory inspections as CSA expert.

Skills

GxP systems

CSV validation

SaaS platforms

Regulatory compliance

Vendor management

Documentation

Education

Bachelor's degree

Tools

Veeva Vault

eQMS

CSV testing tools

Job description

Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager/Associate Director to lead Computer Systems Assurance across QA, IT, and Regulatory. You will own CSA policy, risk-based validation for SaaS/gxP systems, and drive compliance with FDA/ICH guidance, Annex 11, and GAMP 5.

You will partner with Quality, IT, Regulatory Affairs, and Clinical Ops to assure data integrity, change control, and inspection readiness in a lean, virtual biotech environment.