Annexon Biosciences

Annexon Biosciences

Director, Quality Systems

San Francisco Bay Area · Director

Sponsorship not specified$212k-$228kDetected 5 days ago
Clinical TrialsLeadershipGxP

About the role

  • 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.

Responsibilities

  • 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).
  • 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.
  • Partner with functional leaders to ensure timely document review, approval, and training completion across the organization.
  • Conduct periodic internal audits of quality systems and document control process
  • Monitor emerging and evolving global regulatory requirements and proactively drive updates to quality systems and procedures to maintain a continuous state of compliance.

Compensation

  • $212k-$228k

Benefits

  • Lead the administration and optimization of the learning management system, including training curricula, role-based training assignments, and compliance tracking.
  • Develop, monitor, analyze, and report quality system metrics to assess system health and support management review.

Company info

  • 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.
  • 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.
  • 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!
  • 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.
  • 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.
  • include:
  • Quality Systems Leadership
  • Provide governance and oversight of the Annexon Quality Management System, ensuring sustained compliance with applicable GxP regulations.
  • Electronic Quality Systems
  • Computer System Validation & Assurance
  • 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
  • Metrics, Audits & Continuous Improvement
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This listing is sourced directly from Annexon Biosciences's careers page and normalized into a canonical job model.