Clinical Quality Assurance, Specialist II

Arrowhead Pharmaceuticals•Pasadena, CA

1d•$80,000 - $95,000•Hybrid

About The Position

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing medicines for intractable diseases by silencing the genes that cause them. Utilizing a range of RNA chemistries and delivery methods, their therapies activate the RNA interference mechanism for deep and durable gene knockdown. Arrowhead's focus is on diseases with a genetic basis, particularly those involving the overproduction of specific proteins. Their technologies allow them to target diseases in virtually any therapeutic area, including those not addressable by traditional small molecules and biologics. The company is a leader in bringing RNAi therapies beyond the liver, with a clinical pipeline targeting liver and lung diseases and a promising preclinical pipeline. Arrowhead's headquarters are in Pasadena, CA, with R&D teams in Madison, WI, and San Diego, CA, and a manufacturing facility in Verona, WI. The company culture is described as nimble and science-driven, with employees collaborating to bring new therapies to patients.

Requirements

Bachelor’s degree in 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 GCP function providing Quality and Compliance oversight.
Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines.
Competent knowledge of and ability to use Veeva, Microsoft Word, PowerPoint and Excel
Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; Pasadena, CA)

Nice To Haves

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.

Responsibilities

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 (manage report of Serious Breaches).
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.