GMP Investigations Lead, Quality & CAPA

Arrowhead Pharmaceuticals, Inc.; Madison (WI); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking an Integrated Quality Operations Investigation Lead to serve as the QA subject matter expert for nonconformance management across GMP operations from early development to commercial production.

You will partner with Manufacturing, QA, Analytical Development, Supply Chain and external partners to ensure deviations, CAPAs and change controls are thoroughly investigated, documented, and closed on time, with robust RCA and risk assessment.

Competenze

• 5+ years of GMP experience in pharmaceutical/biotech, including deviations, investigations, and CAPAs.
• Knowledge of cGMP and GDP, ICH and FDA/EU guidance.
• Structured root cause analysis methodologies (e.g., 5-Whys, Ishikawa) applied to GMP investigations.

Mansioni

• Serve as the Quality Assurance SME for GMP nonconformance management across early phase, late phase, and commercial operations.
• Partner with cross-functional record owners to initiate, progress, and close deviations, nonconformances, CAPAs, and change controls, coaching on structure and documentation.
• Ensure timely, high-quality investigations with defined, scientifically sound root cause determinations.
• Guide record owners through structured RCA using approved methodologies.
• Review and approve investigation records, challenging conclusions and ensuring scope and product impact are complete.
• Develop and oversee CAPAs to prevent recurrence and verify effectiveness at closure.
• Apply phase-appropriate expectations to investigations as programs progress to commercial production.
• Provide timely investigation conclusions and product impact assessments for disposition decisions.
• Escalate events with potential significant quality risks to management.
• Support quality metrics, trending, and continuous improvement initiatives.
• Collaborate across Manufacturing, Quality Control, Analytical Development, Supply Chain, and external partners to resolve issues.
• Maintain accurate, timely documentation within the QMS for investigations and CAPAs.
• Maintain knowledge of regulatory expectations (21 CFR Parts 210/211, ICH Q7/Q9/Q10, EU GMP) and updates.
• Additional duties as assigned.

Conoscenze

GMP experience

Root cause analysis

Investigation leadership

Quality Assurance

Formazione

Bachelor's Degree in Chemistry, Biology, Engineering, or related field

Strumenti

Veeva

LIMS

Microsoft Office

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking an Integrated Quality Operations Investigation Lead to serve as the QA subject matter expert for nonconformance management across GMP operations from early development to commercial production.

You will partner with Manufacturing, QA, Analytical Development, Supply Chain and external partners to ensure deviations, CAPAs and change controls are thoroughly investigated, documented, and closed on time, with robust RCA and risk assessment.