Associate Director, Computer Systems Assurance (Quality)

Role: Associate Director, Computer Systems Assurance at Nurix, leading the development and execution of the company's CSA and CSV programs to ensure GxP-compliance of SaaS and cloud-based systems across clinical, quality, manufacturing, and regulatory functions. Responsibilities: establish risk-based validation strategies, author and review validation documentation, oversee vendor assessments, support data integrity initiatives, and prepare for inspections; collaborate with cross-functional teams including Quality, IT, and Regulatory Affairs; develop training for stakeholders. Requirements: Bachelor's in science or related field; 7-10+ years in computerized systems validation in a biopharma setting; expertise in FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSA guidance (2022), and validated SaaS/cloud platforms; experience with validation of electronic QMS, clinical data systems, and laboratory informatics is preferred. HighValue: virtual biotech environment, SaaS/cloud validation, GxP systems, data integrity, regulatory inspection support. WorkSetup: onsite in Brisbane, CA; salary range $190K-$217K.