Senior Manager, Client Quality 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

The Senior Manager, Client Quality Management oversees and manages quality-related client and partner interactions, ensuring compliance with internal quality standards and procedures, applicable contracts, license agreements, and Quality Agreements, as well as pharmaceutical industry regulations. This role serves as a key liaison between Arrowhead partners/clients and internal stakeholders to manage notifications and support the resolution of quality related issues, manage expectations, and assist with the transfer of required documentation for review and approval.


Responsibilities

• Lead client and partner quality management activities, ensuring alignment with applicable licensing agreements, contracts, and quality agreements.
• Manage the client notification process.
• Oversee resolution of client quality events, including deviations, change controls, CAPAs, and investigations.
• Oversee and support quality and Alliance/program/project management with the transfer of quality related deliverables, including batch release, document approvals, and other documentation.
• Develop and maintain strong client relationships to enhance transparency and collaboration.
• Partner with and represent Quality at internal cross-functional meetings to support client management.

Requirements

• Bachelor's degree in the life sciences fields or equivalent work experience.
• 7 years of experience in pharmaceutical or other related regulated industry.
• Strong understanding of GxPs including, but not limited to, GMP, GDP, GLP, and GCP, along with global regulatory expectations, and pharmaceutical quality systems.
• Demonstrated client collaboration experience.
• Strong communication, negotiation, and problem-solving skills.

Preferred

• Advanced degree preferred.
• Quality experience within a regulated industry preferred.
• Demonstrated leadership and project management abilities.

Wisconsin pay range


$145,000-$160,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.


Candidates must have current, valid authorization to work in the country where this role is located.

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