Alumis · 2 weeks ago
Director, Clinical Quality Assurance - Contractor
South San Francisco, CA
Full-time, Contract
Onsite
Director/Executive
$193K/yr - $242K/yr
10+ years expAlumis Inc. is a precision medicines company focused on transforming the lives of patients with autoimmune diseases. They are seeking a Clinical Quality Assurance Director to ensure quality throughout the lifecycle of clinical programs, providing oversight and guidance to various teams while ensuring compliance with ICH-GCP/GVP standards.
BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine
Responsibilities
Establish and maintain the ICH-GCP Clinical QA programs, policies, and procedures
Ensure ongoing clinical programs are in compliance with applicable health authority regulations, guidelines and internal Standard Operating Procedures
Act as the primary ICH-GCP Clinical QA subject matter expert and point of contact for all ICH-GCP/GVP related matters and issues for the assigned studies and initiatives
Establish/maintain 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 Clinical QA to Clinical QA meetings
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
Support inspection readiness, plans and activities. Act as the primary liaison with Health Authority and internal/external business partners for the assigned studies and programs
Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports
Qualification
Required
Bachelor's or advanced degree in Biology, Chemistry, or related field
Minimum 10 years of ICH-GCP/GVP Quality Assurance experience
Experience with auditing (e.g. Investigator Sites, Clinical Trial Vendors, Processes)
Strong understanding of small molecule products with direct experience in solid oral dosage forms
Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices
Hands-on experience in drug life cycle management
A successful track record of working with service providers and CROs
Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations
Highly skilled in the ability to work with ambiguity and complexity
Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry
Excellent verbal and written communication skills
Collaborative, analytical and interpretative skills
Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others
Prior management experience is required
Previous experience in successfully leading assigned activities within cross-functional teams
Approximately 15% travel required
Company
Alumis
Alumis is a precision medicine company focused on the discovery, development and treatment of autoimmune disorders.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$872.14MKey Investors
Foresite CapitalMatrix Capital Management
2026-01-08Post Ipo Equity· $300.05M
2025-11-19Secondary Market· $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
2026-01-08
2026-01-08
2026-01-07
Company data provided by crunchbase