Director of QMS — Build a Next-Gen Quality System

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 150,000 - 190,000; Full time

Job summary

Arrowhead Pharmaceuticals seeks a Director of Quality Management Systems to own the GxP QMS across clinical and commercial products in Madison, WI. Lead a team, set global QA strategy, and partner with cross-functional groups to ensure regulatory compliance.

You will drive pre-approval inspection readiness, monitor industry trends, and advance continuous improvement while fostering a strong quality culture.

Qualifications

• Bachelor's degree in life sciences or related field, advanced degree preferred.
• 10+ years in pharmaceutical/biotech with CMO/CRO experience.
• 6+ years in QMS leadership with clinical-to-commercial transition.
• Knowledge of GMP/GDP, ICH/FDA, EU MDR, ISO 13485; regulatory programs.

Responsibilities

• Develop global QMS strategy and processes aligned with regulatory requirements and company goals.
• Manage all GxP QMS functions for clinical and commercial products, incl. Document Control and CAPA.
• Monitor regulatory trends and adapt processes proactively.
• Lead risk assessments using current industry best practices.
• Collaborate with manufacturing, analytical development, QA, regulatory, and development teams.
• Build and lead a high-performing QMS team; foster quality culture.

Skills

GxP Regulations

Leadership

Quality Assurance

Regulatory Liaison

Education

Bachelor's degree in life sciences

Advanced degree preferred (PhD/MS)

Tools

Veeva QualityDocs

TrackWise

Job description

Arrowhead Pharmaceuticals seeks a Director of Quality Management Systems to own the GxP QMS across clinical and commercial products in Madison, WI. Lead a team, set global QA strategy, and partner with cross-functional groups to ensure regulatory compliance.

You will drive pre-approval inspection readiness, monitor industry trends, and advance continuous improvement while fostering a strong quality culture.