Director, Quality Systems
Annexon Biosciences
June 26, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Position: Director, Quality Systems
Responsibilities:
- Provide governance and oversight of the Quality Management System (QMS) to ensure sustained compliance with applicable GxP regulations.
- Monitor evolving global regulatory requirements and proactively update quality systems and procedures to maintain continuous compliance.
- Lead lifecycle management, configuration, and continuous improvement of electronic quality systems (EDMS, LMS, and related GxP platforms).
- Serve as system owner for Veeva Vault Quality (user management, system configuration, document workflows, reporting).
- Lead and support validation activities for GxP computerized systems (Computer System Validation (CSV) and Computer Software Assurance (CSA)).
- Ensure all GxP systems remain validated throughout their lifecycle (change management and periodic review).
- Ensure compliance with 21 CFR Part 11 and applicable electronic records/signature requirements.
- Own and continuously improve document control (authoring, review, approval, distribution, archiving).
- Lead administration and optimization of the learning management system (curricula, role-based training, compliance tracking).
- Develop, monitor, analyze, and report quality system metrics; support management review.
- Conduct internal audits and ensure timely investigation/resolution of gaps or nonconformances.
- Identify and drive continuous improvement initiatives to enhance efficiency, scalability, and compliance.
- Support inspections and audits (regulatory authority and partner audits).
- Contribute to supplier quality, quality risk management, and broader QMS initiatives as needed.
- Perform additional duties as assigned.
Required:
- Bachelor’s degree in a related scientific or technical discipline.
- 10+ years’ industry experience supporting GxP quality systems (biologics, pharmaceuticals, medical devices, or combination products).
- Strong electronic document management system knowledge; Veeva Vault Quality experience preferred.
- Expertise in CSV, CSA, and GxP computerized system lifecycle management.
- In-depth knowledge of FDA, ICH, and global GxP regulations, including 21 CFR Part 11.
- Strong problem-solving, organizational, and communication skills.
- Ability to work independently and collaborate cross-functionally in a fast-paced environment.
- High attention to detail and adaptability; continuous improvement mindset.
Location:
- Brisbane, California; preference for San Francisco Bay Area.
Benefits (as stated):
- Flexible work schedules, remote opportunities, shuttle service, competitive base salary/equity, employee stock purchase plan, and comprehensive health benefits including 401(k) and flexible spending plans.
Responsibilities:
- Provide governance and oversight of the Quality Management System (QMS) to ensure sustained compliance with applicable GxP regulations.
- Monitor evolving global regulatory requirements and proactively update quality systems and procedures to maintain continuous compliance.
- Lead lifecycle management, configuration, and continuous improvement of electronic quality systems (EDMS, LMS, and related GxP platforms).
- Serve as system owner for Veeva Vault Quality (user management, system configuration, document workflows, reporting).
- Lead and support validation activities for GxP computerized systems (Computer System Validation (CSV) and Computer Software Assurance (CSA)).
- Ensure all GxP systems remain validated throughout their lifecycle (change management and periodic review).
- Ensure compliance with 21 CFR Part 11 and applicable electronic records/signature requirements.
- Own and continuously improve document control (authoring, review, approval, distribution, archiving).
- Lead administration and optimization of the learning management system (curricula, role-based training, compliance tracking).
- Develop, monitor, analyze, and report quality system metrics; support management review.
- Conduct internal audits and ensure timely investigation/resolution of gaps or nonconformances.
- Identify and drive continuous improvement initiatives to enhance efficiency, scalability, and compliance.
- Support inspections and audits (regulatory authority and partner audits).
- Contribute to supplier quality, quality risk management, and broader QMS initiatives as needed.
- Perform additional duties as assigned.
Required:
- Bachelor’s degree in a related scientific or technical discipline.
- 10+ years’ industry experience supporting GxP quality systems (biologics, pharmaceuticals, medical devices, or combination products).
- Strong electronic document management system knowledge; Veeva Vault Quality experience preferred.
- Expertise in CSV, CSA, and GxP computerized system lifecycle management.
- In-depth knowledge of FDA, ICH, and global GxP regulations, including 21 CFR Part 11.
- Strong problem-solving, organizational, and communication skills.
- Ability to work independently and collaborate cross-functionally in a fast-paced environment.
- High attention to detail and adaptability; continuous improvement mindset.
Location:
- Brisbane, California; preference for San Francisco Bay Area.
Benefits (as stated):
- Flexible work schedules, remote opportunities, shuttle service, competitive base salary/equity, employee stock purchase plan, and comprehensive health benefits including 401(k) and flexible spending plans.