About the job
At Alumis Inc., we are dedicated to revolutionizing treatment for patients suffering from autoimmune diseases. Despite significant advancements in treatment over the last two decades, many individuals facing immunologic conditions still experience challenges. Our mission is to fundamentally alter the outcomes for these patients.
We are currently seeking a Clinical Quality Assurance Director (Contractor) to join our team, reporting directly to the Executive Director of GCPQA. This pivotal role involves collaborating with Quality leadership and Study Execution Team members to provide expertise in ICH-GCP/GVP for our ongoing clinical studies. The position requires close interaction with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and various other departments across Alumis.
The Clinical QA Director is tasked with ensuring that quality is integrated throughout the entire lifecycle of our clinical programs through comprehensive oversight, evaluation, and monitoring. This includes utilizing risk assessment tools, conducting audits, and implementing risk mitigation strategies. The Director will also play a key role in establishing Key Performance Indicators and Metrics to track the health of our clinical trials.
This position entails providing operational quality guidance for development teams and supporting the Executive Director of GCP Quality in shaping the strategy and vision for the Alumis Quality organization.
The ideal candidate will possess extensive knowledge of Good Clinical and Pharmacovigilance Practices (ICH-GCP & GVP) along with relevant US and EU regulations. We seek a proactive leader who will champion a culture of ethics, integrity, and quality management. Your guidance will be vital in ensuring that our quality functions meet the rigorous standards set by global regulatory authorities.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Establish and maintain ICH-GCP Clinical QA programs, policies, and procedures.
- Ensure compliance of ongoing clinical programs with health authority regulations, guidelines, and internal Standard Operating Procedures.
- Serve as the primary ICH-GCP Clinical QA expert and point of contact for all related matters and initiatives.
- Create and maintain study-specific audit plans; conduct audits and lead external quality auditors as necessary.
- Represent the Quality team on project teams, during Health Authority Inspections, and in operational meetings with service providers and CROs.
- Provide quality oversight and review of critical Clinical and IND/NDA enabling documents.
- Review clinical trial documentation to ensure data integrity and compliance.
