Senior Manager, Integrated Quality Operations

About the role

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.

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