Arrowhead Pharmaceuticals

Develops RNAi-based gene-silencing therapies

Quality Assurance Specialist 2

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeMadison, WI, USA$70k - $85kIn-person

About the Job

Requirements

A bachelor's degree in a scientific field is required.
At least 3 years of GLP/GCLP quality assurance experience in pharmaceutical or contract research organization settings is required.
Knowledge of OECD GLP, FDA/EMA regulations, ICH M10, and 21 CFR Part 11 is required.
Working experience auditing high-performance liquid chromatography, tandem liquid chromatography–mass spectrometry, and enzyme-linked immunosorbent assays is required.
Experience drafting audit reports is required.
The role requires professional communication with external parties, ability to follow company procedures, work instructions, and policies, attention to detail, organizational skills, and ability to work independently with minimal supervision while managing priorities in a fast-paced environment.

Responsibilities

Independently plan, conduct, and report study-specific audits, including method validation and sample analysis phases.
Review and approve study protocols, validation reports, and analytical plans for quality assurance compliance.
Audit raw data, including chromatography and LIMS data, for integrity and regulatory alignment.
Support regulatory readiness efforts, including preparing responses to audit findings.
Manage quality assurance activities across assigned clinical and nonclinical studies.
Lead non-conformance investigations and draft comprehensive corrective and preventive actions.
Identify areas for quality improvement and update audit tools or standard operating procedures accordingly.
Serve as the quality assurance liaison for assigned projects and ensure proper documentation in systems such as LIMS or Vault.
May mentor Quality Assurance Specialist I personnel and contribute to their onboarding.

Desired Qualifications

A master's degree is preferred.
ASQ Certified Quality Auditor certification or equivalent certification is preferred.
Experience supporting biologics, gene therapies, or biomarkers in oncology or rare disease programs is preferred.
Familiarity with electronic systems including Veeva Vault QMS, LIMS, and eTMF is preferred.

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

Provides quality oversight for GLP/GCLP-compliant bioanalytical and biomarker activities. The QA Specialist II is responsible for conducting audits, collaborating with stakeholders, and ensuring that studies are compliant with regulatory standards.

Responsibilities

Independently plan, conduct, and report study-specific audits, including method validation and sample analysis phases.
Review and approve study protocols, validation reports, and analytical plans for QA compliance.
Audit raw data (chromatography, LIMS) for integrity and regulatory alignment.
Support regulatory readiness efforts, including preparing responses to audit findings.
Manage QA activities across assigned clinical and nonclinical studies.
Lead non-conformance investigations and draft comprehensive CAPAs.
Proactively identify areas for quality improvement and update audit tools or SOPs accordingly.
Serve as QA liaison for assigned projects and ensure proper documentation in systems like LIMS or Vault.
May mentor QA Specialist I personnel and contribute to their onboarding.

Requirements

Bachelor’s degree in a scientific field.
3+ years of GLP/GCLP QA experience in pharma or CRO settings.
Knowledge of OECD GLP, FDA/EMA regulations, ICH M10, and 21 CFR Part 11.
Working experience auditing HPLC, LC-MS/MS, and ELISA.
Excellent communication skills and experience drafting audit reports.
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.

Preferred

Master’s degree
ASQ Certified Quality Auditor (CQA) or equivalent certification.
Experience supporting biologics, gene therapies, or biomarkers in oncology or rare disease programs.
Familiarity with electronic systems including Veeva Vault QMS, LIMS, and eTMF.

Wisconsin pay range

$70,000—$85,000 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.

California Applicant Privacy Policy

Wisconsin pay range 70000 - 85000 USD

About the Company

Arrowhead Pharmaceuticals

Develops RNAi-based gene-silencing therapies

Arrowhead Pharmaceuticals develops medicines using RNA interference (RNAi) to silence disease-causing genes. The company’s approach uses a library of RNA chemistries and delivery methods to trigger RNAi, enabling rapid and durable reduction of target gene expression in cells. This gene-silencing strategy aims to treat severe genetic diseases such as cystic fibrosis and hepatitis B by lowering disease-related proteins. Arrowhead’s products are advanced through discovery and development partnerships, licensing deals, and potential commercialization of approved therapies. The company differentiates itself through a broad RNAi platform, proprietary delivery tech, and collaborations with larger pharma firms to advance its pipeline. Its goal is to provide new treatment options for conditions with limited or no effective therapies by translating gene silencing into medicines that can halt or reverse disease progression.

Company size: 501-1,000
Company stage: IPO
Headquarters: Pasadena, CA
Founded: 2004

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