Senior Data Reviewer, Quality Control (2nd shift)
Arrowhead Pharmaceuticals
August 06, 2026
On-site
Madison, WI
Operations
The Position
The Senior Data Reviewer is a technical subject matter expert responsible for oversight of complex laboratory data review activities supporting operations. Provides advanced expertise in data integrity, audit trail review, GMP compliance, and risk-based decision-making to ensure accurate, reliable, and inspection-ready internal and external laboratory data. Leads complex investigations, drives continuous improvement, mentors junior staff, and partners cross-functionally.
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 for deviations, discrepancies, and data integrity concerns
- Ensure data and documentation are maintained in inspection readiness
- Review/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
- Represent the company during regulatory inspections and client audits
- Assess compliance and data integrity risks; develop mitigation strategies and drive CAPA
- Lead continuous improvement initiatives for data review effectiveness, inspection readiness, workflow efficiency, and digital enablement
- Mentor and train Data Reviewers I and II; provide technical guidance
- Partner with leadership to achieve milestones, timelines, and compliance objectives
- Use statistical tools for trend analysis, system suitability trending, deviation investigations, and lab performance
Requirements
- Bachelor’s degree in chemistry (or any STEM) with 8+ years’ experience, or master’s degree with 5+ years in a cGMP laboratory (pharmaceutical CMO/CRO)
- Strong experience with analytical methods + data review + audit trail review
- Deep knowledge of GMP, data integrity, and regulatory expectations
- Working knowledge of analytical methods: HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry, and microbiology testing
Preferred
- Working knowledge of USP, ISO, FDA, and ICH guidelines
- Familiarity with laboratory information systems
- Strong verbal and written communication; matrix collaboration
- Organizational skills; ability to adapt to changing priorities
The Senior Data Reviewer is a technical subject matter expert responsible for oversight of complex laboratory data review activities supporting operations. Provides advanced expertise in data integrity, audit trail review, GMP compliance, and risk-based decision-making to ensure accurate, reliable, and inspection-ready internal and external laboratory data. Leads complex investigations, drives continuous improvement, mentors junior staff, and partners cross-functionally.
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 for deviations, discrepancies, and data integrity concerns
- Ensure data and documentation are maintained in inspection readiness
- Review/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
- Represent the company during regulatory inspections and client audits
- Assess compliance and data integrity risks; develop mitigation strategies and drive CAPA
- Lead continuous improvement initiatives for data review effectiveness, inspection readiness, workflow efficiency, and digital enablement
- Mentor and train Data Reviewers I and II; provide technical guidance
- Partner with leadership to achieve milestones, timelines, and compliance objectives
- Use statistical tools for trend analysis, system suitability trending, deviation investigations, and lab performance
Requirements
- Bachelor’s degree in chemistry (or any STEM) with 8+ years’ experience, or master’s degree with 5+ years in a cGMP laboratory (pharmaceutical CMO/CRO)
- Strong experience with analytical methods + data review + audit trail review
- Deep knowledge of GMP, data integrity, and regulatory expectations
- Working knowledge of analytical methods: HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry, and microbiology testing
Preferred
- Working knowledge of USP, ISO, FDA, and ICH guidelines
- Familiarity with laboratory information systems
- Strong verbal and written communication; matrix collaboration
- Organizational skills; ability to adapt to changing priorities