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. 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-appropriate, tighten appropriately as programs progress, and remain aligned with filed commitments and compendial requirements.