Risk Specialist, Clinical Quality Assurance at Arrowhead Pharmaceuticals

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

100000.0

Posted On

20 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Risk Management, Data Analytics, GxP Compliance, Quality Assurance, Clinical Operations, Computer System Validation, Key Performance Indicators, Issue Management, Training, Data Integrity, Artificial Intelligence, Programming, Scripting, RNA Interference, Biopharmaceuticals, Clinical Studies

Industry

Biotechnology Research

Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops 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. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This position will support the development and maintenance of the Risk Management Platform, contribute to Good Clinical Practice (GCP) data analytics activities, and assist with Computer System Validation (CSV) efforts under the direction of the Senior Manager. The role involves analyzing risks and monitoring risk management efforts through key performance indicators associated with Arrowhead asset / IP, therapeutic areas, clinical studies, and GxP data flows between clinical sites, laboratories, and computerized systems. Key responsibilities include providing data-driven support for audits and inspections, assisting in issue management (non-conformances, deviations, CAPAs), and contributing to risk-based audit planning. The position will collaborate closely with Quality Assurance, Clinical Operations, and R&D teams, offering data-focused insights and operational support to ensure GCP compliance and data integrity. Responsibilities 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. Assist and contribute to the development and maintenance of the Risk Management Platform in collaboration with SMEs under the direction of the Senior Manager Clinical Quality Assurance. Consume, classify, and integrate external and internal data into the Risk Management Platform. Assist with platform and tool research associated with the implementation and advancement of the Risk Management Platform. Communicate risk management mitigations and activities to the Senior Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams. Train and assist members of the Quality Assurance and Clinical Operations and Development teams on the Risk Management Platform, relevant data flows, and risk analysis results and metrics. Facilitate and consult ongoing quality improvement through communication of data and KPI-driven risk management metrics in collaboration with the Senior Manager of Clinical Quality Assurance. Communicate any serious or critical compliance risks noted from these activities to senior management. Participates in the generation, training, evaluation, and execution of Arrowhead Standard Operating Procedures and Work Instructions, as required, in collaboration with the Senior Manager of Clinical Quality Assurance. Issuance, review, tracking, and completion of deviations and CAPAs applicable to job functions. Requirements: Bachelor’s degree in a science discipline is required. 5 years of relevant experience in a Data Analyst role. 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; Pasadena, CA) Preferred: Understanding of development platforms and tools involved with data analytics is a plus (e.g., ETLs). Knowledge in data analytics programming and/or scripting (e.g., Python, SAS) is beneficial. Knowledge of Computer System Validation (CSV) and data integrity audits are beneficial. Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial. Strong knowledge of GCP/GCLP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines. California pay range $80,000—$100,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Responsibilities

The Risk Specialist will support the development and maintenance of the Risk Management Platform and contribute to GCP data analytics activities. The role involves analyzing risks and monitoring risk management efforts through key performance indicators associated with Arrowhead's assets and clinical studies.