Senior Director, Quality Assurance

Summary

Join Annexon Biosciences, a biopharmaceutical company developing novel therapies for neuroinflammatory diseases, as a Senior Director of Quality Assurance. Oversee all GMP activities, ensuring compliance with regulatory requirements and internal standards. Lead and manage QA/QC teams, conducting audits, investigations, and inspections. Approve batch disposition, deviations, and CAPAs. Collaborate with internal and external partners to maintain GMP standards. Present quality performance updates to senior management. This role requires a BS/MS in a life science field, 10-15+ years of GMP experience in biotech/pharma, and strong leadership and communication skills. The position offers a competitive salary, equity participation, comprehensive benefits, and flexible work arrangements.

Requirements

• 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

Responsibilities

• 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

Preferred Qualifications

Veeva experience a plus

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