Associate Director, Computer Systems Assurance

Responsibilities

• Own and maintain the Computer Systems Assurance (CSA) policy framework, SOPs, and risk-based validation strategy
• Define and implement a risk-tiered approach to system qualification for SaaS and cloud-hosted GxP applications
• Lead and execute validation activities for GxP SaaS platforms including eQMS, clinical data management, and LIMS
• Author and review validation documentation such as VMPs, URS, Risk Assessments, and Validation Protocols
• Serve as the internal subject matter expert for 21 CFR Part 11 and EU Annex 11 requirements
• Manage the computerized systems change control process and periodic review program
• Support preparation for regulatory agency inspections and serve as the CSA subject matter expert
• Develop and deliver CSA training for system owners and stakeholders

Requirements

• Bachelor's degree in computer science, information systems, life sciences, or a related field
• 7–10+ years of experience in computer systems validation or assurance in a GxP-regulated environment
• Expertise in FDA 21 CFR Part 11, EU Annex 11, FDA CSA guidance, and GAMP 5
• Hands-on experience validating SaaS and cloud-hosted GxP platforms
• Proficiency in authoring VMPs, URS, Risk Assessments, and IQ/OQ/PQ protocols
• Strong knowledge of data integrity principles (ALCOA+)
• Experience managing system change control and periodic review programs

Preferred Qualifications

• Experience with eQMS validation (e.g., Veeva Vault)
• Familiarity with clinical development platforms (EDC, RIM, CTMS)
• Experience supporting FDA or EMA inspections as a CSA subject matter expert
• Exposure to laboratory informatics systems (LIMS, ELN)
• Experience in a lean or virtual biotech environment
• Working knowledge of cybersecurity frameworks like NIST or SOC 2

About the Company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines to improve treatment options for patients with cancer and inflammatory diseases.