Head of Computer Systems Assurance - GxP Validation Leader

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

Job summary

Nurix Therapeutics is seeking an Associate Director, Computer Systems Assurance to lead its CSA program in a fast-paced biotech setting. You will own the validation framework across SaaS and cloud platforms supporting GxP activities in clinical development, quality operations, and regulatory submissions.

The role requires deep regulatory knowledge, hands-on CSV experience, and the ability to translate complex requirements into pragmatic, risk-based validation approaches.

Qualifications

• Bachelor's degree in a relevant field.
• 7-10+ years in computer systems validation or assurance in GxP environments.
• Strong knowledge of FDA 21 CFR Part 11 and EU Annex 11.
• Experience with SaaS/cloud platforms and vendor-managed ecosystems.
• Ability to translate regulatory requirements into pragmatic validation approaches.

Responsibilities

• Own and advance the CSA program and validation strategy.
• Lead validation activities for SaaS/GxP platforms and oversee documentation.
• Coordinate testing with cross-functional teams and ensure fit-for-purpose validation.
• Ensure compliance with 21 CFR Part 11, Annex 11, and data integrity principles.
• Support inspections and contribute to regulatory submissions.

Skills

Regulatory knowledge

Documentation

Vendor management

Program ownership

Written & verbal communication

Education

Bachelor's degree in computer science, information systems, life sciences, pharmaceutical sciences, or related

Tools

Veeva Vault

SaaS platforms

Cloud-based GxP systems

Job description

Nurix Therapeutics is seeking an Associate Director, Computer Systems Assurance to lead its CSA program in a fast-paced biotech setting. You will own the validation framework across SaaS and cloud platforms supporting GxP activities in clinical development, quality operations, and regulatory submissions.

The role requires deep regulatory knowledge, hands-on CSV experience, and the ability to translate complex requirements into pragmatic, risk-based validation approaches.