Senior Specialist, Quality Assurance

Arrowhead Pharmaceuticals•Verona, WI

13h•$90,000 - $110,000

About The Position

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 purpose of this position is to provide quality assurance oversight and execution for Arrowhead’s Supplier Quality Assurance (SQA) program, focusing on the evaluation, qualification, and maintenance of material suppliers to ensure compliance with cGMP and regulatory requirements. This role is an integral part of the SQA team responsible for governance across the supplier lifecycle (from initial supplier evaluation through ongoing supplier management) and will interact extensively with external suppliers and internal cross-functional departments. The Senior Specialist serves as a key quality liaison, ensuring that material controls meet Arrowhead’s quality standards and support ongoing commercial and clinical development programs.

Requirements

Bachelor’s degree in an applicable scientific field (e.g. Chemistry, Biochemistry, Biotechnology), or equivalent combination of related education and experience.
Minimum of eight years of quality assurance experience in a GMP-regulated biotechnology or pharmaceutical organization, with significant experience in supplier and material quality processes.
Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents.
Strong focus on quality and attention to detail as well as effective time management and organizational skills.
Ability to consistently communicate with external suppliers in a professional manner.

Nice To Haves

Prior experience with use of an electronic document management system in a regulated environment.
Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, DocuSign, and SmartSheet.
Excellent interpersonal, verbal, and written communication skills.
Ability to consistently communicate with external parties in a professional manner.
Ability to follow company procedures, work instructions, and policies.
Excellent attention to detail and organizational skills.
Ability to work independently with minimal supervision as well as manage priorities within a fast-paced environment.

Responsibilities

Oversee raw material lifecycle management activities, including authoring, reviewing, and providing final SQA approvals for material specifications and qualification protocols/reports, and ensuring all materials remain in compliance with periodic requalification requirements.
Initiate and assess change controls for impact to material supplier quality management, process impact, and patient safety.
Ensure that all necessary supporting material technical documentation (e.g. manufacturing production records, CoAs, CoCs, BSE/TSE statements) are properly requested, collected, and reviewed to support GMP manufacturing activities and material lifecycle management.
Lead risk-based material evaluation processes, including conducting material criticality assessments and formal quality risk assessments for materials and suppliers. Ensure risk evaluations inform qualification requirements and supplier control strategies.
Provide oversight for supplier-related quality events and non-conformances, partnering with suppliers and internal stakeholders to investigate and resolve issues (e.g. documentation discrepancies, material non-conformances). Oversee Supplier Corrective Action Request (SCAR) execution, including initiating, reviewing, and approving material SCARs in accordance with Arrowhead procedures and the applicable quality agreements.
Monitor, analyze, and report material supplier quality performance metrics (e.g. SCAR rates) and drive continuous improvement initiatives or supplier business reviews based on data insights.
Author, update, and review Quality System documents (SOPs, work instructions, forms) as related to supplier quality and materials.
Perform other related Quality Assurance and Supplier Quality duties as assigned.