Senior CAPA Specialist, Quality & Investigations

Arrowhead Pharmaceuticals, Inc.; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Senior CAPA Investigator to lead CAPA projects within the Quality Management System, ensuring timely, compliant closure of quality events through root-cause analysis and effective corrective actions.

You will collaborate with cross-functional teams, perform investigations using Six Sigma, 5 Whys, and fishbone methods, and ensure actions are aligned with FDA, EU, and ICH GxP requirements.

Qualifications

• Bachelor’s degree in engineering or life sciences in a related field.
• Minimum of five years in a regulated pharma/biotech environment with CAPA/QA experience.
• Demonstrated use of quality tools and compliance with GxP regulations.

Responsibilities

• Lead CAPA projects, ensuring timely and compliant closure.
• Perform root cause analyses using structured methodologies (Six Sigma, 5 Whys, fishbone).
• Collaborate with cross-functional teams on corrective and preventive actions.
• Support CAPA documentation, audits, and regulatory inspections.
• Communicate metrics and trends to management.

Skills

CAPA execution

Root cause analysis

Structured problem solving

Quality Assurance

Cross-functional leadership

Education

Bachelor's degree in engineering or life sciences

Tools

MS Word

Excel

Smartsheet

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Senior CAPA Investigator to lead CAPA projects within the Quality Management System, ensuring timely, compliant closure of quality events through root-cause analysis and effective corrective actions.

You will collaborate with cross-functional teams, perform investigations using Six Sigma, 5 Whys, and fishbone methods, and ensure actions are aligned with FDA, EU, and ICH GxP requirements.