Director, Quality Systems

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 Huntingtons 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 youll 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.

Were seekingexceptional talent from all backgrounds to fuel our growth. At Annexon were building a diverse equitable and inclusive workplace. We value unique perspectives and unconventional paths. If youre the best candidate for the job even if you dont perfectly fit the traditional mold we encourage you to more about our commitment to diversity equity inclusion and our companyculture!

Position:

TheDirector Quality Systemsprovides strategic leadership and hands-on oversight for the design implementation maintenance and continuous improvement of theAnnexonQuality Management System (QMS). This role serves as a subject matter expert forGxPquality 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 theAnnexonQuality Management System ensuring sustained compliance with applicableGxPregulations.

• • Monitor emerging and evolving global regulatory requirements and proactively drive updates to quality systems and procedures tomaintaina continuous state of compliance.

Electronic Quality Systems

• • Lead the lifecycle management configuration and continuous improvement of electronic quality systems including EDMS LMS and relatedGxPplatforms.

• • 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 forGxPcomputerized systemsdemonstratingexpertisein Computer System Validation (CSV) and Computer Software Assurance (CSA).

• • Ensure allGxPsystemsremainin 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 ensuretimelydocument 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; ensuretimelyinvestigation and resolution of identified gaps or nonconformances.

• • Identifyand 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.

• • • Performadditionalduties as assigned by management.

Education Experience and Skills:

Required:

• Bachelors degree ina relatedscientific or technical disciplinerequired.

• Minimum of ten (10) years of industry experience supportingGxPquality systems withinbiologics pharmaceuticals medical devices or combination products.

• Strong working knowledge of electronic document management systems;Veeva Vault Quality experience highly preferred.

• Demonstratedexpertisein CSV CSA andGxPcomputerized system lifecycle management.

• In-depth understanding of FDA ICH and globalGxPregulations 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 comfortoperatingin a growing clinical-stage organization.

Salary Range: $212300 - $228000

Location: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.

Annexon Biosciences is an Equal Opportunity Employer and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths views and experiences. We believe that our differences enable us to be a better team one that makes better decisions drives innovation and delivers better business results. Creativity and innovation flourish in an environment of openness inclusion and mutual respect.