Sr. Director, Quality Assurance

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: 

Senior Director, Quality Assurance (QA) is responsible for ensuring that manufacturing and quality operations comply with all regulatory and internal standards, leading QA/QC teams, managing audits and inspections, and driving continuous improvement across GMP processes.  

Responsibilities include: 

• Oversee all GMP activities to ensure compliance with regulatory requirements (FDA, EMA, ICH, etc.) and the internal quality standards  
• Maintain and organize GMP related documentation, systems and programs records  
• Manage and execute the GMP audit programs, including conducting qualifications audits, supporting investigations and ensuring inspection readiness  
• Provide leadership and direction for Quality Assurance (QA) and Quality Control (QC) teams, including hiring, training, and performance evaluations  
• Approve batch disposition, deviations, change controls, and corrective and preventive actions (CAPA)  
• Lead cross functional teams to resolve complex quality and compliance issues, drive continuous improvement, and implement process optimization  
• Maintain and improve Quality Management Systems (QMS) ensuring effective management of batch records, audits, investigations, and compliance metrics  
• Collaborate with internal and external partners, including contract manufacturers (CDMO), to ensure manufacturing processes meet GMP standards and regulatory expectations  
• Prepare and present updates on quality performance, risks, and issues to senior management  
• Oversee regulatory inspections and responses, and ensure training programs are in place for GMP compliance  

Education, Experience, and Skills: 

Required:

• B.S./M.S. in life science, biotechnology or a related field 
• Extensive experience 10-15+ in GMP, quality assurance, or manufacturing within the biotechnology or pharmaceutical industry standards (e.g. CFR, GLP)
• Strong leadership, communication, and problem-solving skills, with a proven ability to manage teams and complex projects 
• Able to work effectively with cross functional teams
• Veeva experience a plus 

Salary Range: $245,000 to $273,000

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area. This position may be on-site or remote (within the US).

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.