Senior Manager, Quality Management System Programs

Job Description

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq : ARWR) is a clinical 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

Work cross-functionally to drive and champion projects related to continuous improvement of the systems, processes, and functions comprising the GxP Quality Management System (QMS), while ensuring compliance with regulatory requirements, industry standards, and company policies in support of the development, manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). Provide expertise on the collective systems comprising the QMS, including the technical functions within Quality Engineering (QE).

Responsibilities

• Coordinate and facilitate stakeholder involvement as systems are continuously monitored and improved to augment compliance and increase efficiencies.
• Identify, champion, and drive improvements to streamline and upgrade the QMS processes in the following areas :

Document Control & Training : EDMS / EQMS, document lifecycle management, training program design and administration

Requirements :

Preferred :

Wisconsin pay range

$130,000—$150,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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