Senior Director of Clinical Quality Assurance

About This Role

Lead and manage the Clinical Quality Assurance program for Alumis Inc., focusing on compliance with ICH-GCP/GVP and relevant US/EU regulations for ongoing clinical studies. Drive quality oversight, auditing, and risk mitigation across clinical programs to transform the lives of patients with autoimmune diseases.

Responsibilities

• Establish and maintain GCP QA programs, policies, and procedures
• Ensure ongoing clinical programs comply 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 study-specific audit plans, 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, preparing KPIs 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, acting 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

Requirements

• Minimum 12 years of GCP/GVP Quality Assurance experience
• Strong understanding of small molecule products with direct experience in solid oral dosage forms
• Expertise in Good Clinical and Pharmacovigilance Practices and relevant US and EU regulations

Qualifications

• Bachelor’s or advanced degree in Biology, Chemistry, or related field
• Minimum 12 years of GCP/GVP Quality Assurance experience

Benefits