Senior QA Engineer - Validation & GMP Systems

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 130,000 - 190,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking an experienced Quality Assurance leader to support commercialization programs. The role focuses on qualification, cleaning validation, process validation and CPV within GMP and cGMP frameworks.

You will mentor QA team members, review validation documentation, and collaborate with cross-functional groups to ensure compliant, scalable manufacturing processes for biologics and gene therapies.

Qualifications

• Bachelor's degree in a science field is required.
• 15+ years of experience in cGMP-regulated manufacturing, specifically in validation-related roles.
• Strong knowledge of GMP regulations (21 CFR Part 210/211, EU Annex 11/15, ICH Q7, 21 CFR Part 11).
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.

Responsibilities

• Serve as QA subject matter expert on qualification, cleaning validation, process validation and CPV, including guidance and approval of validation activities.
• Draft, review, and approve procedures to support quality systems for qualification and validation.
• Mentor QA team members in quality engineering functions and audits.
• Collaborate with cross-functional teams to review internal and vendor data for validation activities.
• Support deviations, change controls, and CAPAs related to validation.
• Develop and implement periodic reviews for validated systems and CPV procedures for commercial manufacturing.
• Provide support for audits and documentation reviews.

Skills

Quality Assurance

Validation

GMP Regulations

Documentation

Communication

Education

Bachelor's degree in Science

Tools

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking an experienced Quality Assurance leader to support commercialization programs. The role focuses on qualification, cleaning validation, process validation and CPV within GMP and cGMP frameworks.

You will mentor QA team members, review validation documentation, and collaborate with cross-functional groups to ensure compliant, scalable manufacturing processes for biologics and gene therapies.