Company:
At Annexon Biosciences we are 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. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.
For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.
We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture!
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.
