Alumis

Director, Clinical Quality Assurance - Contractor

South San Francisco · Director · Contract

Sponsorship not specifiedDetected 2 days ago

GCPAuditingSupply ChainFDA RegulatoryPharmacovigilanceLeadershipCommunicationGxP

About the role

Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
Alumis is hiring a Clinical Quality Assurance Director, (CONTRACTOR) reporting to the Executive Director, GCPQA.
This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other teams across Alumis.

Establish and maintain the ICH-GCP Clinical QA programs, policies, and procedures.
Establish/maintain the study specific audit plan; perform audits and lead a team of external quality auditors as needed.
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 clinical service provider selection and qualification activities and develop periodic compliance/metric reports.
The role works closely with the Quality leadership and Study Execution Team members to provide ICH-GCP/GVP support for all ongoing clinical studies.
The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management.
The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities.
Support inspection readiness, plans and activities.

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.
Knowledge/Skills/Abilities
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
Education & Experience
Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
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.
Excellent verbal and written communication skills.
Collaborative, analytical and interpretative skills.

The Director will assist with establishing Key Performance Indicators and Metrics to trend and track on the health of the clinical trials.
The role is responsible for providing the operational quality guidance for the development teams and supporting the Executive Director of GCP Quality in building the Alumis Quality organization strategy and vision.
Ensure ongoing clinical programs are in compliance with applicable health authority regulations, guidelines and internal Standard Operating Procedures.
Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and Clinical QA to Clinical QA meetings.
Act as the primary liaison with Health Authority and internal/external business partners for the assigned studies and programs.

This listing is sourced directly from Alumis's careers page and normalized into a canonical job model.