Alumis · 5 hours ago
Senior Director of Clinical Quality Assurance
South San Francisco, CA
Full-time
Hybrid
Director/Executive
$236K/yr - $295K/yr
12+ years expAlumis Inc. is a precision medicines company focused on transforming the lives of patients with autoimmune diseases. They are seeking a Senior Director of Clinical Quality Assurance to ensure quality throughout the clinical programs, providing oversight, assessment, and monitoring while leading the quality strategy and vision within the organization.
BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine
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
Qualification
Required
Minimum 12 years of GCP/GVP Quality Assurance experience
Strong understanding of small molecule products with direct experience in solid oral dosage forms
Bachelor's or advanced degree in Biology, Chemistry, or related field
Benefits
Health insurance premiums paid at 90% for employee, 80% for dependents
Free access to Genentech Bus & Ferry Share program
$100 monthly cell phone stipend
Unlimited PTO for Exempt employees
Free onsite gym and a kitchen stocked with yummy snacks and drinks!
Company
Alumis
Alumis is a precision medicine company focused on the discovery, development and treatment of autoimmune disorders.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$917.19MKey Investors
Foresite CapitalMatrix Capital Management
2026-01-07Post Ipo Equity· $345.1M
2025-11-19Post Ipo Secondary· $3.09M
2024-07-23Post Ipo Equity· $40M
Leadership Team
Martin Babler
Chairman, President and CEO
K
Ken A Brameld
Fellow, Head of Discovery
Recent News
thefly.com
2026-01-16
Company data provided by crunchbase