Specialist II, Clinical Quality Assurance

The Position

The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance.

Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs, SCARs), contributing to risk-based audit planning, support in audits and inspections, procedural reviews and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity.

Responsibilities

• Develop and maintain clinical quality study risk plans and maintain updates in the Quality Management System (QMS).
• Collect site metrics for selection of investigator site audits while analyzing and reporting trends.
• Lead and participate in internal audits to identify gaps, ensure adherence to policies, and drive corrective actions.
• Assist with audit-related data entry in the QMS and documentation to maintain accurate and organized records and do develop dashboards for internal sharing.
• Conduct periodic reviews of SOPs to verify compliance with regulatory requirements and organizational standards.
• Support in the issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs.
• Provide QA support for clinical study programs with GCP compliance, as needed.
• Assist during health authority inspections, including document management and logistical coordination.
• Support and contribute to risk management analysis efforts associated with GCP functions.
• Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level.
• Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams.
• Facilitate ongoing quality improvement through communication of audit results and CAPAs
• Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches).
• Keep up to date with all related quality legislation and compliance issues.

Requirements:

• Bachelor’s degree in a science discipline is required.
• 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience.
• 2 years of relevant experience in GxP function providing Quality and Compliance oversight.
• Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; San Diego, CA)

Preferred: 

• Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines.
• Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva).
• Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial.