Director, Quality Systems
Annexon BiosciencesBrisbane, California, United States · Posted 4 months agoDescription
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.
Similar jobs
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 120,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 85,000 USD
Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from…
Est. 140,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 140,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 85,000 USD
Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from…
Est. 115,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 85,000 USD
Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from…
Est. 139,550 USD
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech”…
Est. 85,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 120,000 USD
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell thera…
Est. 120,000 USD
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, ta…
Est. 140,000 USD
Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual…
Est. 124,000 USD
About our Company: Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the d…
Est. 85,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 85,000 USD
At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to meas…
Est. 140,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 120,000 USD
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, p…
Est. 115,000 USD
About Lucid At Lucid, we are creating exceptional mobility experiences through innovation to drive the world forward. Built on Lucid’s proprietary technology and software-defined vehicle architecture, our award-winning v…
Est. 140,000 USD
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, ta…
Est. 140,000 USD
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medic…
Est. 105,000 USD
About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trus…
Est. 124,000 USD
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, p…
Est. 120,000 USD
At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to meas…
Est. 162,500 USD
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech”…
Est. 165,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 151,850 USD
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech”…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 120,000 USD
Company Description Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in ca…
Est. 120,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…