Early Phase QA Lead - Quality Operations

Arrowhead Pharmaceuticals, Inc.; Verona (WI); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Competitive benefits

Competitive salary

Job summary

Arrowhead Pharmaceuticals, Inc. in Verona, WI is seeking a Senior Manager to lead Quality Operations for early phase clinical programs. The role ensures GMP oversight across drug substance, product, packaging, labeling, storage, and distribution, from preclinical to Phase 2.

The candidate will mentor QA staff, coordinate with internal departments and external partners, and maintain inspection readiness while ensuring compliance with US and international regulations.

Qualifications

• Bachelor’s degree in a science field.
• 10+ years of pharmaceutical/biotech QA experience, including early phase GMP operations.
• Direct experience overseeing external manufacturing and testing partners.
• Strong knowledge of US and international GMP regulations and guidance.

Responsibilities

• Lead the Operational Quality Assurance team for early phase programs, including hiring and performance management.
• Serve as QA contact for external partners (CDMOs/CMOs, labs, suppliers).
• Provide GMP quality oversight of internal operations (manufacturing, labs, warehouse, supply chain).
• Review and approve critical docations: master/executed batch records, COAs, labeling, specs, reports.
• Disposition of drug substance/product for early phase use per specifications and IND/CTA/IMPD.
• Support deviation/investigation/CAPA/change control processes and risk management.
• Assist with vendor qualification, requalification, and disqualification as SME.
• Provide quality leadership for test article characterization and clinical materials.

Skills

QA oversight

GMP compliance

CAPA & deviations

Documentation control

Leadership

Regulatory knowledge

Education

Bachelor's degree in a science field

Job description

Arrowhead Pharmaceuticals, Inc. in Verona, WI is seeking a Senior Manager to lead Quality Operations for early phase clinical programs. The role ensures GMP oversight across drug substance, product, packaging, labeling, storage, and distribution, from preclinical to Phase 2.

The candidate will mentor QA staff, coordinate with internal departments and external partners, and maintain inspection readiness while ensuring compliance with US and international regulations.