PJob Description /ppArrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines to 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. /ppArrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved with disease. The depth and versatility of our RNAi technologies enable 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, with a clinical pipeline that includes disease targets in the liver and lung, along with a promising pipeline of preclinical candidates. /ppArrowhead's corporate headquarters is in Pasadena, CA, with research and development teams in Madison, WI, and San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators collaborating to bring new therapies to patients in need. /ppstrongThe Position /strong /ppThis position will work within the cGMP, GLP, and GCP-regulated Quality organization to provide validation and lifecycle support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced, or modified. The incumbent will be responsible for guiding, generating, reviewing, and/or approving system assessments, test scripts, change controls, process improvements, and data integrity and governance at the applicable points of the system lifecycle. The position will serve as a subject matter expert, providing compliance leadership and oversight for CSV projects, and collaborating with business partners to maintain and improve computer system validation processes. /ppemResponsibilities /em /pulliProvide Quality guidance for CSV efforts related to requirements engineering, system risk assessments, and data integrity assessments. /liliReview and approve validation documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Functional Requirements Specifications, Testing Protocols, Requirements Trace Matrices, and Summary Reports. /liliServe as an SME for CSV and maintain knowledge and information in the Computer System Validation area of expertise. /liliReview CSV documentation to ensure data integrity requirements are maintained. /liliReview and approve discrepancies/deviations encountered during qualification/validation activities. /liliReview, assess, and approve computerized system change controls. /liliCoordinate validation activities with key stakeholders. /liliProvide direction to validation contractors, if required. /liliCommunicate CSV approach in support of audits. /liliPrepare documentation and support regulatory inspections and inspection readiness activities. /liliReview and approve periodic reviews of system validation, ensuring appropriate remediation plans are determined for gaps identified during periodic reviews. /li /ulpstrongRequirements /strong /pulliBachelor's degree in an applicable science field. /liliAdditional Quality-related certification desired, such as CQA or CQMP. /liliMinimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization with responsibilities related to computerized system, equipment, and/or instrument qualification. /liliWorking knowledge of GMP and/or GLP FDA, EU, and ICH regulations. /li /ulpstrongPreferred Experience /strong /pulliPrior experience with electronic document management systems in a regulated environment. /li /ulpWisconsin pay range: $80,000—$95,000 USD. /ppArrowhead offers competitive salaries and an excellent benefits package. /ppAll applicants must have authorization to work in the US. /ppCalifornia Applicant Privacy Policy /p #J-18808-Ljbffr