Senior Manager, Integrated 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 Integrated Quality Operations team for Arrowhead's product portfolio and holds day-to-day accountability for quality oversight of programs starting with pre-clinical test article characterization and spanning across early phase clinical development through late phase clinical and commercial supply, including programs where early and late phase/commercial activities run in parallel. The Senior Manager applies phase-appropriate GMP requirements across raw materials, drug substance, drug product, packaging, labeling, storage, and distribution for both internal operations and external suppliers. Core accountabilities include QA release of GMP raw materials and components, product release and stability data review, specification lifecycle management, and subject matter expert ownership of quality events, including deviations, OOS/OOT results, and CAPA. 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 GMP Operations Quality Assurance team supporting early phase, late phase, and commercial programs, including hiring, management, mentoring, performance management, and workload planning. Provide GMP quality oversight applying phase-appropriate requirements to programs that span clinical and commercial supply for areas including nonconformances and out of specification results. Own QA release of GMP raw materials, including review of supplier documentation and certificates of analysis, incoming inspection and testing records, and compendial and regulatory compliance; make final raw material disposition decisions. Own QA review and approval of the release and stability program, including release and stability protocols/reports, QA data review, stability OOS/OOT results, assignment and extension of retest dates and expiry, and stability commitments supporting regulatory filings and ongoing supply. Own specification lifecycle management for intermediates, drug substance, and drug product, including creation, review, approval, periodic review, and version control; work collaboratively with the other stakeholders including regulatory, CMC, and analytical development to ensure acceptance criteria are phase-appropria