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Arrowhead Pharmaceuticals · 1 month ago

Specialist II, Clinical Quality Assurance

San Diego, California, United States

Full-time

Onsite

Mid Level

$80K/yr - $95K/yr

3+ years exp

Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Clinical Quality Assurance Specialist will ensure compliance with GCP standards, support audit programs, and collaborate cross-functionally to uphold clinical trial quality and regulatory compliance.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

GCP complianceQuality AssuranceAuditingFDA regulationsElectronic document managementRisk managementData integrityContinuous improvementCommunication skillsTeam collaboration

Required

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