Director, Clinical Quality Assurance - Contractor

Role Summary

Director, Clinical Quality Assurance (Contractor) at Alumis Inc. The role provides ICH-GCP/GVP support for ongoing clinical studies, collaborating with Quality leadership and cross-functional teams to embed a culture of ethics and proactive quality management. The position develops and maintains QA programs, oversees audits and risk mitigation, and supports inspection readiness, with a focus on small molecule clinical programs and solid oral dosage forms. Location: South San Francisco, CA; onsite Tuesday–Thursday.

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.

Qualifications

• 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 global health authority regulations.
• Hands-on experience in drug life cycle management.
• A proven 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; adept at working with ambiguity and complexity.
• Knowledge of Quality Management Systems; experience implementing and managing quality systems in the pharmaceutical industry.
• Excellent verbal and written communication skills; collaborative, analytical and interpretative abilities.
• Ability to work with minimal supervision, set priorities to meet timelines, and motivate/influence others; prior management experience required.
• Experience leading cross-functional teams and activities.
• Approximately 15% travel required.

Education

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

Additional Requirements

• Onsite presence in South San Francisco, CA (Tuesday–Thursday).