Senior Manager, Clinical and PV Quality Assurance; Inspection Readiness and Management

Position: Senior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management)
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 Provide strategic leadership for the company's global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs by overseeing inspection readiness, regulatory inspection management, internal quality audits, and partner audit activities.

Lead the Inspection Readiness and Management Program, serving as the primary Inspection Lead responsible for planning, hosting, facilitating, and directing regulatory inspections conducted by the FDA (BIMO), MHRA, PMDA, EMA, and other global Health Authorities, including Pharmacovigilance post-marketing inspections. Lead and execute a risk-based internal GCP/GVP audit program and oversee partner and alliance audits to evaluate compliance with applicable regulations, industry standards, and company procedures.

Partner with executive leadership and cross-functional stakeholders to maintain a continuous state of inspection readiness, ensure effective execution of regulatory inspections and audits, foster high-quality regulatory interactions, and drive timely responses to inspection and audit observations, CAPAs, and continuous improvement initiatives. Provide strategic leadership across Clinical Operations, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biometrics, Data Management, Quality, and external partners to promote sustainable compliance, operational excellence, and inspection success throughout the product development lifecycle.

This role is based in Pasadena with an expectation to be in office 5 days a week.

Responsibilities Own the global GCP/GVP Inspection Readiness Program and establish governance that maintains continuous inspection readiness.

Serve as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections, including PV post-marketing surveillance inspections.

Lead all inspection planning activities including scope, logistics, agendas, inspection rooms, virtual inspection platforms, document management, and inspection communication plans.

Facilitate and direct inspection management activities before, during, and after inspections, ensuring alignment across stakeholders and executive leadership.

Chair…