Director, Quality Systems

Responsibilities

• Provide governance and oversight of the Annexon Quality Management System, ensuring sustained compliance with applicable GxP regulations
• Monitor emerging and evolving global regulatory requirements and proactively drive updates to quality systems and procedures
• Lead the lifecycle management, configuration, and continuous improvement of electronic quality systems, including EDMS, LMS, and related GxP platforms
• Serve as system owner for Veeva Vault Quality, including user management, system configuration, document workflows, and reporting
• Lead and support validation activities for GxP computerized systems using CSV and CSA expertise
• Ensure all GxP systems remain in a validated state through change management and periodic review
• Ensure compliance with 21 CFR Part 11 and applicable electronic records and signature requirements
• Own and continuously improve the document control process
• Lead the administration and optimization of the learning management system
• Develop, monitor, analyze, and report quality system metrics
• Conduct periodic internal audits of quality systems and document control processes
• Support inspections and audits from regulatory authorities and partners

Requirements

• Bachelor’s degree in a related scientific or technical discipline
• Minimum of 10 years of industry experience supporting GxP quality systems in biologics, pharmaceuticals, medical devices, or combination products
• Strong working knowledge of electronic document management systems
• Demonstrated expertise in CSV, CSA, and GxP computerized system lifecycle management
• In-depth understanding of FDA, ICH, and global GxP regulations, including 21 CFR Part 11

Preferred Qualifications

• Veeva Vault Quality experience

Benefits

• Flexible work schedules and remote opportunities
• Shuttle service from BART, CalTrain, and the Ferry
• Competitive base salary and equity participation
• Employee stock purchase plan
• Comprehensive health benefit package including medical, dental, and vision
• 401(k) and flexible spending plans

About the Company

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye.