Senior Data Reviewer, Quality Control (2nd shift)

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing 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. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved in disease. Arrowhead’s RNAi-based therapeutics leverage the natural pathway of gene silencing, enabling the potential to address conditions across virtually any therapeutic area.

About the role

The Senior Data Reviewer serves as a technical subject matter expert responsible for oversight of complex laboratory data review activities supporting operations. This role provides advanced expertise in data integrity, audit trail review, GMP compliance, and risk-based decision-making to ensure the accuracy, reliability, and inspection readiness of internal and external laboratory data. The Senior Data Reviewer leads complex investigations, drives continuous improvement initiatives, mentors junior staff, and partners cross-functionally to strengthen compliant and efficient review practices.

Responsibilities

• Perform advanced technical review of internal data and external CDMO datasets for compliance with specifications, GDP, and data integrity requirements
• Serve as SME for data integrity, audit trail review, and documentation standards
• Lead complex data review investigations, compliance assessments, and root cause evaluations related to deviations, discrepancies, and data integrity concerns
• Ensure all data and documentation are maintained in a state of inspection readiness
• Review and approve routine release and stability data, method validation data and reports, cleaning data, IPC data, and critical manufacturing support records
• Provide oversight of external laboratory/CDMO data quality and compliance
• Serve as a primary representative during regulatory inspections, client audits, and compliance assessments
• Assess compliance and data integrity risks, develop mitigation strategies, and drive corrective and preventive actions to reduce operational and regulatory risk
• Lead continuous improvement initiatives focused on strengthening data review effectiveness, inspection readiness, workflow efficiency, and digital enablement strategies
• Mentor and train Data Reviewers I and II; provide technical guidance and troubleshooting support
• Partner with leadership to ensure milestones, timelines, and compliance objectives are achieved
• Influence departmental procedures, review standards, and compliance strategies through technical expertise and risk-based decision-making
• Embrace statistical tools for trend analysis, system suitability trending, deviation investigations, and overall laboratory performance
• Other duties as assigned

Requirements

• Bachelor’s degree in chemistry or any STEM field and 8+ years of experience, or master’s degree and 5+ years of experience in a cGMP laboratory (pharmaceutical CMO/CRO)
• Strong experience with analytical methods, data review, and audit trail review
• Deep knowledge of GMP, data integrity, and regulatory expectations
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry, and microbiology testing

Preferred Qualifications

• Working knowledge of USP, ISO, FDA, and ICH guidelines
• Familiarity with laboratory information systems
• Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment
• Solid organizational skills with ability to adapt to changing priorities and deadlines

Schedule

2nd shift work hours are 1 pm – 11:30 pm, Monday - Thursday, and includes a 10% shift differential.

Pay

Wisconsin pay range: $100,000 USD - $110,000 USD

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.