Director, Quality Systems

divh2Director, Quality Systems/h2pSan Francisco Bay Area/ppAt 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-Barr 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./ppWere seeking exceptional 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 apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture!/ppThe 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./ppThe Director partners cross-functionally to ensure inspection-ready quality systems that meet global regulatory requirements, support clinical-stage development, and scale with organizational growth./ppResponsibilities include:/ppQuality Systems Leadership/pulliProvide governance and oversight of the Annexon Quality Management System, ensuring sustained compliance with applicable GxP regulations./liliMonitor emerging and evolving global regulatory requirements and proactively drive updates to quality systems and procedures to maintain a continuous state of compliance./li/ulpElectronic Quality Systems/pulliLead the lifecycle management, configuration, and continuous improvement of electronic quality systems, including EDMS, LMS, and related GxP platforms./liliServe as system owner for Veeva Vault Quality, including user management, system configuration, document workflows, and reporting./li/ulpComputer System Validation Assurance/pulliLead and support validation activities for GxP computerized systems, demonstrating expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA)./liliEnsure all GxP systems remain in a validated state throughout their lifecycle, including change management and periodic review./liliEnsure compliance with 21 CFR Part 11 and applicable electronic records and signature requirements./li/ulpDocument Control Training/pulliOwn 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./liliLead the administration and optimization of the learning management system, including training curricula, role-based training assignments, and compliance tracking./liliPartner with functional leaders to ensure timely document review, approval, and training completion across the organization./li/ulpMetrics, Audits Continuous Improvement/pulliDevelop, monitor, analyze, and report quality system metrics to assess system health and support management review./liliConduct periodic internal audits of quality systems and document control processes; ensure timely investigation and resolution of identified gaps or nonconformances./liliIdentify and drive continuous improvement initiatives to enhance efficiency, scalability, and compliance of quality systems./li/ulpAdditional Quality Support/pulliSupport inspections and audits, including regulatory authority and partner audits./liliContribute to supplier quality, quality risk management, and broader QMS initiatives as needed./liliPerform additional duties as assigned by management./li/ulpEducation, Experience, and Skills:/ppRequired:/pulliBachelors degree in a related scientific or technical discipline required./liliMinimum of ten (10) years of industry experience supporting GxP quality systems within biologics, pharmaceuticals, medical devices, or combination products./liliStrong working knowledge of electronic document management systems; Veeva Vault Quality experience highly preferred./liliDemonstrated expertise in CSV, CSA, and GxP computerized system lifecycle management./liliIn-depth understanding of FDA, ICH, and global GxP regulations, including 21 CFR Part 11./liliStrong problem-solving, organizational, and communication skills./liliAbility to work independently while effectively collaborating in a cross-functional, fast-paced environment./liliHigh attention to detail with the agility to adapt to changing priorities./liliContinuous improvement mindset and comfort operating in a growing clinical-stage organization./li/ulpSalary Range: $212,300 - $228,000/ppLocation: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area./ppBenefits:/pulliA stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance./liliShuttle service from BART, CalTrain and the Ferry./liliAnnexon 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./li/ulpAnnexon 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./p/div