Senior Director, Quality Control

Role: Lead the Quality Control (QC) Laboratory at Arrowhead Pharmaceuticals, overseeing analytical, microbial, stability, and reference standard testing across oligonucleotide and biologics platforms. Objectives include establishing and optimizing QC processes, ensuring GMP compliance, and leading the transition from clinical to commercial readiness. Responsibilities involve managing a multi-manager QC team, setting strategic vision, operational planning, budgeting, and resource allocation. The role also requires ensuring QC support for manufacturing, process validation, and regulatory inspections, notably serving as a QC representative during FDA Pre-Approval Inspections. Qualifications: 15+ years in GxP pharma/biotech industries; 7+ years of direct QC operations leadership in a cGMP setting, including managing budgets and multiple managers; Master's degree in a scientific field, with PhD preferred. High-value specifics include expertise in GMP, FDA, ICH regulations, and supporting FDA PAI and commercial launches. The position entails close collaboration with Manufacturing, MSAT, Regulatory, and Analytical Development teams. Work setup is on-site in Verona, WI, with some travel expected.