GMP Investigation Lead, Quality Control

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 resides within the Quality Control function under the Quality Organization. The GMP Lead Investigator is responsible for leading, authoring, and managing deviations; OOS/OOT/Atypical laboratory investigations; and associated change control records arising from analytical testing activities. These activities include testing of environmental monitoring samples, pharmaceutical raw materials, in‑process manufacturing samples, finished drug substances and drug products, and stability samples for new drug substances and drug products within a GMP environment.

The incumbent will embody a GMP‑compliant quality mindset, driving excellence, continuous improvement, and ethical practices to ensure regulatory compliance and sustain the highest standards of quality. The GMP Lead Investigator serves as the primary Quality Control representative, overseeing and coordinating all investigation‑related activities conducted by the Quality Control team.

Responsibilities

* Serve as Lead investigator and ensure the timely completion of high quality, robust GMP investigations with clearly defined and scientifically sound root cause determination

* Develop, justify, and oversee the implementation of effective Corrective and Preventative Actions, (CAPAs) to prevent recurrence.

* Conduct structured, science-based root cause analysis (RCA) using approved methodologies (5-Whys, Ishikawa, Fault Tree, etc)

* Escalate events to management when they represent potential significant quality risks or may impact investigations closure timelines or product release

* Support regulatory inspections and internal/external audits by maintaining inspection readiness and serving as a subject matter expert (SME) as needed.

* Contribute to site Quality Operations compliance activities in alignment with Arrowhead standards, procedures and cGMP requirements.

* Collaborate cross functionally with site personnel to provide guidance and drive resolution of end-to-end manufacturing and quality issues.

* Ensure accurate, complete, timely documentation and review of Quality Control investigations, CAPAs, Change Controls and complainants.

* Evaluate historical data, trends and prior investigations for recurrence or systemic issues and opportunities for proactive improvement.

* Support the maintenance and improvement of investigation compliance metrics

* Participate in and contribute to continuous improvement initiatives related to the investigation and CAP processes.

* Work independently while also collaborating effectively with cross - functional partners, including…