Position: The
Director, Quality Systems provides strategic leadership and hands-on oversight for the design, implementation, maintenance, and continuous improvement of the Annexon Quality Management System (QMS). This role serves as a subject matter expert for GxP quality systems and is accountable for system governance, compliance, and operational excellence across electronic quality platforms.
The Director partners cross-functionally to ensure inspection-ready quality systems that meet global regulatory requirements, support clinical-stage development, and scale with organizational growth.
Responsibilities include: Quality Systems Leadership - 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.
Electronic Quality Systems - 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.
Computer System Validation & Assurance - 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.
Document Control & Training - 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.
Metrics, Audits & Continuous Improvement - 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.
Additional Quality Support - 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.
Education, Experience, and Skills: Required: - 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.
Salary Range: $212,300 - $228,000Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.
Benefits: - A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- Shuttle service from BART, CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.
