Senior Data Reviewer, Quality Control

The Senior Data Reviewer serves as a technical subject matter expert responsible for oversight of complex laboratory data review activities supporting operations, ensuring accuracy, reliability, and inspection readiness through data integrity, audit trail review, GMP compliance, and risk-based decision-making.

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 data and documentation are maintained in inspection readiness
- Review and approve routine release and stability data, method validation data and report, 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, client audits, and compliance assessments
- Assess compliance and data integrity risks; develop mitigation strategies; drive CAPA
- Lead continuous improvement (data review effectiveness, inspection readiness, workflow efficiency, digital enablement)
- Mentor/train Data Reviewers I and II; provide technical guidance and troubleshooting
- Partner with leadership to meet milestones, timelines, and compliance objectives
- Influence procedures, review standards, and compliance strategies using technical expertise and risk-based decisions
- Use statistical tools for trend analysis and system suitability trending
- Other duties as assigned

Requirements:
- Bachelor’s degree in chemistry or any STEM degree + 8+ years, or master’s degree + 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
- Experience with 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/written communication; ability to work in a matrix environment
- Solid organizational skills; ability to adapt to changing priorities

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