Director, Quality Systems
Annexon Biosciences
August 09, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Director, Quality Systems
Responsibilities:
- Provide governance and oversight of the Quality Management System (QMS) to ensure sustained GxP compliance.
- Monitor evolving global regulatory requirements and update quality systems/procedures to maintain compliance.
- Lead lifecycle management/configuration/continuous improvement of electronic quality systems (EDMS, LMS, related GxP platforms).
- Serve as system owner for Veeva Vault Quality (user management, system configuration, document workflows, reporting).
- Lead/support validation for GxP computerized systems using CSV and CSA; ensure systems remain validated through lifecycle via change management and periodic review.
- Ensure compliance with 21 CFR Part 11 and electronic records/signatures.
- Own and continuously improve document control (author/review/approve/distribute/archive).
- Lead LMS administration/optimization (curricula, role-based assignments, compliance tracking).
- Develop/monitor/analyze quality system metrics; conduct internal audits and drive resolution of gaps/nonconformances.
- Drive continuous improvement initiatives; support inspections/audits (regulatory and partner) and contribute to supplier quality and quality risk management.
Required qualifications & skills:
- Bachelor’s degree (scientific/technical).
- 10+ years industry experience supporting GxP quality systems in biologics/pharma/medical devices/combination products.
- Strong electronic document management knowledge; Veeva Vault Quality preferred.
- Expertise in CSV, CSA, and GxP computerized system lifecycle management.
- In-depth FDA/ICH/global GxP regulations knowledge (including 21 CFR Part 11).
- Strong problem-solving, organizational, and communication skills; independent and collaborative in fast-paced cross-functional environments; attention to detail; continuous improvement mindset.
Benefits (as stated):
- Flexible schedules, remote opportunities, work-life balance; shuttle service; base salary ($212,300–$228,000), equity, ESPP, and comprehensive medical/dental/vision, 401(k), flexible spending plans, and other benefits.
Responsibilities:
- Provide governance and oversight of the Quality Management System (QMS) to ensure sustained GxP compliance.
- Monitor evolving global regulatory requirements and update quality systems/procedures to maintain compliance.
- Lead lifecycle management/configuration/continuous improvement of electronic quality systems (EDMS, LMS, related GxP platforms).
- Serve as system owner for Veeva Vault Quality (user management, system configuration, document workflows, reporting).
- Lead/support validation for GxP computerized systems using CSV and CSA; ensure systems remain validated through lifecycle via change management and periodic review.
- Ensure compliance with 21 CFR Part 11 and electronic records/signatures.
- Own and continuously improve document control (author/review/approve/distribute/archive).
- Lead LMS administration/optimization (curricula, role-based assignments, compliance tracking).
- Develop/monitor/analyze quality system metrics; conduct internal audits and drive resolution of gaps/nonconformances.
- Drive continuous improvement initiatives; support inspections/audits (regulatory and partner) and contribute to supplier quality and quality risk management.
Required qualifications & skills:
- Bachelor’s degree (scientific/technical).
- 10+ years industry experience supporting GxP quality systems in biologics/pharma/medical devices/combination products.
- Strong electronic document management knowledge; Veeva Vault Quality preferred.
- Expertise in CSV, CSA, and GxP computerized system lifecycle management.
- In-depth FDA/ICH/global GxP regulations knowledge (including 21 CFR Part 11).
- Strong problem-solving, organizational, and communication skills; independent and collaborative in fast-paced cross-functional environments; attention to detail; continuous improvement mindset.
Benefits (as stated):
- Flexible schedules, remote opportunities, work-life balance; shuttle service; base salary ($212,300–$228,000), equity, ESPP, and comprehensive medical/dental/vision, 401(k), flexible spending plans, and other benefits.