Senior Quality Specialist, CAPA Investigations at Arrowhead Pharmaceuticals in Verona, WI

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 Serve as a senior contributor to the Corrective and Preventive Action (CAPA) program within the Quality Management System (QMS), facilitating and executing CAPA and investigation activities to support ongoing development and commercial programs at Arrowhead. Provide oversight of CAPA record processing, root cause analysis, and effectiveness checks to ensure timely, compliant, and quality-driven resolution of quality events. Partner with cross-functional teams and subject matter experts to ensure root causes are thoroughly investigated, corrective and preventive actions are appropriately implemented, and CAPAs are closed in alignment with regulatory requirements and quality goals. Responsibilities CAPA and Investigation Execution Participate in or lead CAPA projects, ensuring records are completed with appropriate quality, compliance, and timeliness. Lead investigation into quality events, gather relevant data, and perform preliminary root cause analysis using structured problem-solving methodologies, such as Six Sigma, 5 Whys, and fishbone analysis. Partner with subject matter experts to ensure root causes are thoroughly investigated, product impact to Safety, Identity, Strength, Purity, and Quality (SISPQ) is assessed, and appropriate corrective and preventive actions are identified. Establish appropriate CAPA ownership and timelines based on the risk associated with the event or issue. Process CAPA requests by assigning owners and supporting timely responses and approvals in alignment with quality goals. Assess final supporting documentation for adequacy prior to CAPA closure and conduct effectiveness checks for high-risk CAPAs. Communication, Metrics, and Governance Coordinate and support CAPA Quality Review Board (QRB) meetings, including agenda preparation, meeting minutes, and tracking follow-up action items to closure. Communicate CAPA and investigation metrics, trends, and escalations to management and key stakeholders in a clear and timely manner. Provide input to trend review reporting and lifecycle review activities to support identification and resolution of process shifts and emerging trends. Compile and prepare CAPA and investigation metrics and reports on a routine basis in accordance with established procedures. Training, Systems, and Inspection Support Serve as a subject matter expert and trainer for the electronic CAPA/investigation modu