GCP Compliance Expert

2 weeks ago


South San Francisco, California, United States Alumis Full time
Transforming Patient Lives: Our Mission

At Alumis Inc., we are driven by a vision to revolutionize the treatment landscape for patients with autoimmune diseases. We believe that quality is paramount, and our mission is to embed it throughout every stage of our clinical programs.


About the Role

We seek a seasoned Clinical Quality Assurance Director to lead our efforts in ensuring the quality and integrity of our clinical programs. As a critical member of our team, you will play a pivotal role in guaranteeing compliance with regulatory requirements and industry best practices.


Key Responsibilities
  • GCP QA Program Development: Establish, maintain, and continuously improve GCP QA programs, policies, and procedures to ensure compliance with applicable health authority regulations and guidelines.
  • Clinical Trial Oversight: Ensure ongoing clinical programs are conducted in accordance with GCP and GVP principles, providing operational quality guidance to development teams.
  • Inspection Readiness: Develop and implement inspection readiness plans and activities, acting as the primary liaison with the Health Authority and internal/external business partners.

Requirements and Qualifications

To excel in this role, you will need a strong background in GCP/GVP Quality Assurance, preferably with 12+ years of experience in the pharmaceutical industry. A bachelor's or advanced degree in a relevant field is essential, along with expertise in FDA regulations and practices, ICH guidance, and global health authority regulations.


Compensation and Benefits

We offer a highly competitive salary range of $260,000 USD - $275,000 USD annually, complemented by a comprehensive benefits package, including health insurance premiums paid at 90% for employees and 80% for dependents, free access to the Genentech Bus & Ferry Share program, and unlimited PTO for exempt employees. Our compensation packages also include generous stock option grants for all employees as well as an annual bonus program.



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