Clinical Quality Assurance Manager

6 days ago


Pasadena, California, United States Arrowhead Pharmaceuticals Full time

Arrowhead Pharmaceuticals is seeking a highly skilled Clinical Quality Assurance Manager to join our team in Pasadena, CA. As a key member of our quality assurance department, you will be responsible for ensuring compliance with Good Clinical Practice (GCP) standards and regulations.

About the Role

The ideal candidate will have a minimum of 5 years of experience in GCP, investigator site audits, and compliance. A strong background in authoring, reviewing, and managing controlled documents is also essential. In addition, the selected individual must possess excellent communication and problem-solving skills.

Key Responsibilities
  • Develop and maintain clinical quality study risk plans and updates in the Quality Management System
  • Share risk plans and updates with functional QA leads
  • Collect site metrics for the selection of investigator site audits
  • Implement and update investigator site audit annual plans
  • Participate in program and protocol team meetings as the QA representative
Requirements
  • A minimum of a bachelor's degree in a Science discipline
  • A minimum of 5 years of relevant experience in GCP, investigator site audits, and compliance
  • Experience administering deviation and/or CAPA processes
  • Experience authoring, reviewing, and managing controlled documents
  • Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations, and ICH guidelines
What We Offer

We offer a competitive salary range of $125,000 - $145,000 per year, depending on experience. Additionally, we provide an excellent benefit package, including health insurance, retirement plan, and paid time off.



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