Investigation Lead, Quality Operations

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.

This position resides within the Integrated Quality Operations function under the Quality organization. The Quality Operations Investigation Lead serves as the Quality Assurance subject matter expert for nonconformance management across GMP operations, supporting programs from early phase clinical development through late phase and commercial production. The position partners with QMS record owners across Manufacturing, Quality Control, Analytical Development, Supply Chain, Facilities and Engineering, and external partners to ensure that deviations, nonconformances, OOS/OOT and atypical results, CAPAs, and associated change control records are investigated thoroughly, documented accurately, and closed on time.

These activities span raw materials, in-process manufacturing, environmental monitoring, drug substance and drug product, packaging and labeling, storage and distribution, and stability, with phase-appropriate GMP expectations applied as programs progress toward commercial supply. The Investigation Lead serves as the primary Quality Assurance representative for investigation-related activities, guiding and coaching record owners rather than owning the records on their behalf.

• Serve as the Quality Assurance subject matter expert for GMP nonconformance management across early phase clinical, late phase, and commercial operations.
• Partner with QMS record owners across functions to initiate, progress, and close deviations, nonconformances, OOS/OOT and atypical results, CAPAs, and associated change controls, coaching owners on investigation structure, evidence collection, and documentation expectations.
• Ensure the timely completion of high quality, robust GMP investigations with clearly defined and scientifically sound root cause determination.
• Guide record owners through, and where needed personally lead, structured science-based root cause analysis (RCA) using approved methodologies (5-Whys, Ishikawa, Fault Tree, etc).
• Review and approve investigation records as the Quality Assurance subject matter expert/reviewer, challenging conclusions and verifying the scope of impact, product impact, and…