Director, Quality Systems

Qualifications

• 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.
• Strong working knowledge of electronic document management systems; Veeva Vault Quality experience highly preferred.
• Demonstrated expertise in CSV, CSA, and GxP computerized system lifecycle management.
• In-depth understanding of FDA, ICH, and global GxP regulations, including 21 CFR Part 11.

Skills

• 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 comfort operating in a growing clinical-stage organization.

Pay

Salary Range: $212,300 - $228,000

Schedule

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.
• 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.

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.