Senior Manager, Early Phase Quality Operations 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 This position leads the Quality Operations for Arrowhead's early phase clinical programs and holds day-to-day accountability for quality oversight of both internal operations and external partners. The Senior Manager provides phase-appropriate GMP oversight across drug substance, drug product, packaging, labeling, storage, and distribution activities supporting pre-clinical test article as well as first-in-human through Phase 2 clinical supply. Core accountabilities include management of batch record review and investigational product disposition, quality event and change management, clinical distribution related activities, QP support for product supplied to studies outside the US, and inspection readiness. The candidate will be expected to interact with multiple internal departments, external vendors, and partners, and will lead, develop, and plan capacity for the QA staff supporting these activities. This role is full-time onsite, 5 days a week in Verona, WI. Responsibilities Lead the Operational Quality Assurance team supporting early phase clinical programs, including hiring, management, mentoring, performance management, and workload planning. Serve as the primary QA point of contact and oversight owner for external partners, including CDMOs/CMOs, contract testing laboratories, clinical packaging and labeling suppliers, clinical supply depots and distributors supporting early phase studies. Provide phase-appropriate GMP quality oversight of internal operations supporting early phase clinical material, including manufacturing, laboratory, warehouse, and supply chain activities. Review and approve internal and vendor generated documentation, including master batch records, executed batch records, clinical label text and labeling, specifications, certificates of analysis, qualification protocols and reports, stability data, and testing records. Perform final review and disposition (release/reject) of drug substance, drug product, and finished packaged investigational product for early phase clinical use, in accordance with approved specifications and the applicable IND/CTA/IMPD. Assist with quality event management for internal and external early phase operations, including deviations, investigations, OOS/OOT results, root cause analysis, CAPA, effectiveness checks, and change control; escalate significant issues to the Director, Operational Quality. S