Senior Manager - Early Phase Quality Ops (Onsite, Verona)

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

Job summary

Arrowhead Pharmaceuticals, Inc. in Verona, WI seeks a Senior Manager to lead Early Phase Quality Operations.

You will provide phase-appropriate GMP oversight for drug substance, product, packaging, labeling, storage, and distribution across pre-clinical to Phase 2, ensuring QA support for both internal and external activities. The role requires 10+ years in pharma/biotech QA, strong leadership, and experience with external manufacturers, deviations, CAPA, and regulatory expectations.

Qualifications

• Bachelor's degree in science field with 10+ years in pharma/biotech QA, including early phase GMP operations.
• Experience overseeing external manufacturers and testing partners, batch review and product disposition.
• Strong knowledge of US/intl GMP guidance and IND/CTA/IMPD processes.

Responsibilities

• Lead the Operational Quality Assurance team for early phase programs (hiring, mentoring, workload planning).
• Oversee external partners (CDMOs/CMOs, testing labs, packaging suppliers) for QA.
• Provide GMP QA oversight of internal operations (manufacturing, lab, warehouse, supply chain).
• Review and approve documentation including master/ executed batch records and labeling.
• Dispostion of drug substance/product for early phase use per specs and IND/CTAs.
• Support CAPA, deviations, investigations, change controls and risk assessments.

Skills

QA oversight

Leadership

Regulatory knowledge

GMP compliance

Vendor management

Quality systems

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Arrowhead Pharmaceuticals, Inc. in Verona, WI seeks a Senior Manager to lead Early Phase Quality Operations.

You will provide phase-appropriate GMP oversight for drug substance, product, packaging, labeling, storage, and distribution across pre-clinical to Phase 2, ensuring QA support for both internal and external activities. The role requires 10+ years in pharma/biotech QA, strong leadership, and experience with external manufacturers, deviations, CAPA, and regulatory expectations.