Senior Director of Clinical Quality Assurance

Role Summary

Senior Director of Clinical Quality Assurance at Alumis. The role provides ICH-GCP and GVP support for ongoing clinical studies and collaborates with Quality leadership and the Study Execution Team across Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other teams. The Senior Director ensures quality is embedded throughout the lifecycle of all clinical programs through oversight, assessment, monitoring, risk assessment tools, auditing, and risk mitigations, and leads KPIs to track trial health. The role provides operational quality guidance for development teams and helps build the Alumis Quality organization strategy and vision. Requires expertise in Good Clinical and Pharmacovigilance Practices and relevant US/EU regulations to foster a culture of ethics, integrity, and proactive quality management. Location: South San Francisco, CA; onsite Tuesday-Thursday.

Responsibilities

• Establish and maintain the GCP QA programs, policies, and procedures.
• Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines.
• Act as the primary GCP QA subject matter expert and point of contact for all GCP/GVP related matters and issues.
• Establish the study specific audit plan; perform audits and lead a team of external quality auditors as needed.
• Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings.
• Manage Quality Review Board meetings content and material. Prepare KPI and metrics.
• Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
• Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations.
• Conduct root cause analysis for recurring issues.
• Determine the strategy for and lead the implementation of inspection readiness plans and activities. Act as the primary liaison with Health Authority and internal/external business partners.
• Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.

Qualifications

• Minimum 12 years of GCP/GVP Quality Assurance experience.
• Strong understanding of small molecule products with direct experience in solid oral dosage forms.

Education

• Bachelor’s or advanced degree in Biology, Chemistry, or related field.