Director, Quality Systems

Position

Director, Quality Systems

• 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 to maintain a continuous state of compliance.
• 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, demonstrating expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Ensure all GxP systems remain in a validated state throughout their lifecycle, including 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, ensuring controlled documents are authored, reviewed, approved, distributed, and archived in compliance with internal procedures and regulatory expectations.
• Lead the administration and optimization of the learning management system, including training curricula, role‑based training assignments, and compliance tracking.
• Partner with functional leaders to ensure timely document review, approval, and training completion across the organization.
• Develop, monitor, analyze, and report quality system metrics to assess system health and support management review.
• Conduct periodic internal audits of quality systems and document control processes; ensure timely investigation and resolution of identified gaps or nonconformances.
• Identify and drive continuous improvement initiatives to enhance efficiency, scalability, and compliance of quality systems.
• Support inspections and audits, including regulatory authority and partner audits.
• Contribute to supplier quality, quality risk management, and broader QMS initiatives as needed.
• Perform additional duties as assigned by management.

• Bachelor’s degree in a related scientific or technical discipline required.
• Minimum of ten (10) years of industry experience supporting GxP quality systems within biologics, pharmaceuticals, medical devices, or combination products.
• Strong working knowledge of electronic document management systems;
  Veeva Vault Quality experience highly preferred.
• 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.
• Strong problem‑solving, organizational, and communication skills.
• Ability to work independently while effectively collaborating in a cross‑functional, fast‑paced environment.
• High attention to detail with the agility to adapt to changing priorities.
• Continuous improvement mindset and comfort operating in a growing clinical‑stage organization.

$212,300 - $228,000

Annexon Biosciences is located in Brisbane, California, and preference is given to candidates in the San Francisco Bay Area.

• Flexible work schedules, remote opportunities, and the ability to achieve a work‑life balance.
• Shuttle service from BART, Cal Train, and the Ferry.
• Competitive base salary and equity participation, employee stock purchase plan, and a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible‑spending plans, and other benefits.

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where all people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results.

Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.