Clinical Quality Assurance, Specialist II

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved in disease. Arrowhead’s RNAi-based therapeutics leverage the natural pathway of gene silencing and address conditions across virtually any therapeutic area, including targets not otherwise addressable by small molecules and biologics.

About the role

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

Responsibilities

• Develop and maintain clinical quality study risk plans and updates in the Quality Management System.
• Collect site metrics for selection of investigator site audits; analyze and report trends in audit findings.
• Support and lead internal audits.
• Support QMS (Veeva) Audit entry and dashboard management.
• Review SOPs.
• Facilitate ongoing quality improvement through communication of audit results, CAPAs, and other quality events.
• Issue, track, and ensure 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 serious or critical compliance risks to senior management (manage reports of Serious Breaches).
• Stay updated with all related quality legislation and compliance issues.
• Support and contribute to risk management analysis efforts associated with GxP functions (primarily GCP).
• Assist in risk identification at the asset/IP, therapeutic area, clinical study, clinical site, and vendor levels.
• Identify KPIs involved with risk monitoring from internal and external sources.
• Communicate risk management mitigations and activities to the Manager of Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams.

Requirements

• Bachelor’s degree in a science discipline is required.
• 3 years of relevant experience in a regulated environment, with preference for quality assurance, auditing, and/or GCP experience.
• 2 years of relevant experience in a GCP function providing Quality and Compliance oversight.
• Strong knowledge of GCP, FDA, European regulations, and ICH guidelines.
• Competent knowledge of and ability to use Veeva, Microsoft Word, PowerPoint, and Excel.
• Occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; Pasadena, CA).

Preferred Qualifications

• Prior experience with an electronic document management system in a regulated environment (e.g., Veeva).
• Knowledge of using or building Artificial Intelligence (AI) models (e.g., training dataset creation, validation, and reassessment).

Pay

California pay range: $80,000 USD - $95,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.