Clinical Quality Assurance, Specialist II
Arrowhead Pharmaceuticals
August 12, 2026
Remote friendly (Los Angeles, CA)
United States
Clinical Research and Development
The Clinical Quality Assurance Specialist will support GCP and Quality Assurance activities to ensure compliance with GCP standards, including investigator audit programs, risk management plans, regulatory inspections, continuous improvement metrics, and quality events—collaborating cross-functionally to uphold clinical trial quality and regulatory compliance.
Responsibilities:
- Develop and maintain clinical quality study risk plans and keep updates in the Quality Management System.
- Collect site metrics for investigator site audit selection and analyze/report audit finding trends.
- Support and lead internal audits.
- Support QMS (Veeva) audit entry and dashboard.
- Perform SOP review.
- Facilitate ongoing quality improvement through communication of audit results, CAPAs, and other quality events.
- Issue, track, and complete deviations, SCARs, and CAPAs.
- Support clinical study programs with GCP compliance, as needed.
- Support health authority inspections.
- Communicate serious/critical compliance risks to senior management (manage report of Serious Breaches).
- Stay current on related quality legislation and compliance issues.
- Support GxP risk management analysis efforts (primarily GCP) and risk identification (asset/IP, therapeutic area, clinical study/site, vendors).
- Identify KPIs for risk monitoring from internal/external sources.
- Communicate risk mitigations and activities to relevant teams.
Requirements:
- Bachelor’s degree in a science discipline (required).
- 3 years relevant experience in a regulated environment (preferred QA/auditing/GCP).
- 2 years relevant experience in GCP with Quality/Compliance oversight.
- Strong knowledge of GCP and FDA, European regulations, and ICH guidelines.
- Proficiency with Veeva, Microsoft Word, PowerPoint, and Excel.
- Occasional travel to San Diego, CA; Verona, WI; Pasadena, CA.
Preferred:
- Experience with electronic document management systems in regulated environments (Veeva).
- Knowledge of/beneficial experience with AI or building AI models.
Compensation (California): $80,000–$95,000 USD.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities:
- Develop and maintain clinical quality study risk plans and keep updates in the Quality Management System.
- Collect site metrics for investigator site audit selection and analyze/report audit finding trends.
- Support and lead internal audits.
- Support QMS (Veeva) audit entry and dashboard.
- Perform SOP review.
- Facilitate ongoing quality improvement through communication of audit results, CAPAs, and other quality events.
- Issue, track, and complete deviations, SCARs, and CAPAs.
- Support clinical study programs with GCP compliance, as needed.
- Support health authority inspections.
- Communicate serious/critical compliance risks to senior management (manage report of Serious Breaches).
- Stay current on related quality legislation and compliance issues.
- Support GxP risk management analysis efforts (primarily GCP) and risk identification (asset/IP, therapeutic area, clinical study/site, vendors).
- Identify KPIs for risk monitoring from internal/external sources.
- Communicate risk mitigations and activities to relevant teams.
Requirements:
- Bachelor’s degree in a science discipline (required).
- 3 years relevant experience in a regulated environment (preferred QA/auditing/GCP).
- 2 years relevant experience in GCP with Quality/Compliance oversight.
- Strong knowledge of GCP and FDA, European regulations, and ICH guidelines.
- Proficiency with Veeva, Microsoft Word, PowerPoint, and Excel.
- Occasional travel to San Diego, CA; Verona, WI; Pasadena, CA.
Preferred:
- Experience with electronic document management systems in regulated environments (Veeva).
- Knowledge of/beneficial experience with AI or building AI models.
Compensation (California): $80,000–$95,000 USD.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.