Associate Director, Quality Engineering

Arrowhead Pharmaceuticals, Inc.

Verona, Wisconsin, United States
Base: $155,000 - $175,000 usd; bonus/equity: not s...
On-site
10 years regulated pharmaceutical experience
6 years leadership in commercial manufacturing
Gxp regulations gmp ich iso standards knowledge
Arrowhead Pharmaceuticals is seeking an Associate Director of Quality Engineering to provide strategic leadership in managing quality systems and processes for pharmaceutical products. The ideal candidate should have extensive experience in the regulated biotech industry, with a strong focus on compliance and operational excellence

Job Summary

  • Arrowhead Pharmaceuticals is a commercial stage biopharmaceutical company developing RNA interference-based medicines for intractable diseases.
  • The role requires providing strategic leadership to manage Quality Engineering elements including asset lifecycle management and process validation.
  • Candidates must have a minimum of ten years of experience in the regulated pharmaceutical industry with six years in a leadership role.

Matching Summary

Match Score: 85

Arrowhead Pharmaceuticals is seeking an Associate Director of Quality Engineering to provide strategic leadership in managing quality systems and processes for pharmaceutical products. The ideal candidate should have extensive experience in the regulated biotech industry, with a strong focus on compliance and operational excellence.

Salary

Base: $155,000 - $175,000 USD; Bonus/Equity: Not specified; Benefits: Excellent benefit package included

Skills & Requirements

Must-have

  • 10 years regulated pharmaceutical experience
  • 6 years leadership in commercial manufacturing
  • GxP regulations GMP ICH ISO standards knowledge
  • Change and risk management expertise
  • Facility utility equipment CQV process validation
  • Cleaning validation and environmental monitoring

Nice-to-have

  • Advanced degree in science or engineering
  • ASQ ISPE PDA certification or training
  • Active engagement with professional organizations
  • Experience with QMS tools and workflows
  • Ability to influence stakeholders at all levels

Key Requirements

  • Bachelor's degree in science or engineering
  • Minimum 10 years pharmaceutical/biotech experience
  • Minimum 6 years leadership in commercial manufacturing
  • Comprehensive knowledge of FDA EU GMP and ICH guidelines
  • Valid work authorization in the United States

Work Rights

Must have current valid authorization to work in the US

Tailored Resume

Cover Letter