Clinical Quality Assurance, Specialist II
$80,000–$95,000 year
On-sitePasadena, California, United States
Job Summary
Develop and maintain clinical quality study risk plans within the Quality Management System, while collecting site metrics to analyze audit trends and inform investigator site selection. Lead internal audits, support regulatory inspections, and manage the issuance, tracking, and completion of deviations, SCARs, and CAPAs. Facilitate ongoing quality improvement by communicating audit results and critical compliance risks to senior management, ensuring adherence to GCP standards and FDA regulations. Collaborate cross-functionally with Clinical Operations and Development teams to uphold data integrity and regulatory compliance across clinical study programs.
Required Qualifications
- Bachelor's degree in science discipline
- 3 years of relevant experience in a regulated environment
- preference to quality assurance, auditing and/or GCP experience
- 2 years of relevant experience in GCP function providing Quality and Compliance oversight
- Strong knowledge of GCP
- Strong knowledge of Food & Drug Administration (FDA)
- Strong knowledge of European regulations
- Strong knowledge of ICH guidelines
- Competent knowledge of and ability to use Veeva
- Competent knowledge of and ability to use Microsoft Word
- Competent knowledge of and ability to use PowerPoint
- Competent knowledge of and ability to use Excel
- Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; Pasadena, CA)
Desired Qualifications
- Prior experience with use of an electronic document management system in a regulated environment
- Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment)
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