Clinical Quality Assurance Specialist II - San Diego

Job overview

The Clinical Quality Assurance Specialist II - San Diego is an onsite role based in San Diego, CA. Compensation is $80,000–$95,000 per year. This role supports the Quality Assurance department at Arrowhead Pharmaceuticals. This role exists to ensure clinical trial quality and regulatory compliance by supporting GCP standards. The specialist manages quality events, contributes to risk management plans, and collaborates cross-functionally to uphold data integrity and compliance with FDA and ICH guidelines.

What you'll do

• Develop and maintain clinical quality study risk plans and maintain updates in Quality Management System
• Collect site metrics for selection of investigator site audits while analyzing and reporting trends in audit findings
• Support and lead internal audits
• Support QMS (Veeva) Audit entry, dashboard
• SOP review
• Facilitate ongoing quality improvement through communication of audit results, CAPAs and other quality events
• Issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs
• Provide support for clinical study programs with GCP compliance, as needed
• Support health authority inspections
• Communicate any serious or critical compliance risks noted from these activities to senior management
• Keep up to date with all related quality legislation and compliance issues
• Support and contribute to risk management analysis efforts associated with GxP functions (primarily GCP)
• Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level
• Identify KPIs involved with risk monitoring from internal and external sources
• Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams.

What we're looking for

Skills & competencies

full-time

day shift

san diego ca

clinical

quality assurance

gcp

pharmaceuticals

compliance

regulatory

$80k-$95k/yr

Work arrangement

• Weekend coverage required

Benefits & perks

• Competitive salaries, Excellent benefit package, Innovative biopharmaceutical environment.

Why this role

Competitive salaries, Excellent benefit package, Innovative biopharmaceutical environment.

About the employer

Arrowhead Pharmaceuticals is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.