QC Director, Commercial Readiness & Compliance

Socket.dev; Verona (WI); On-site; USD 220,000 - 255,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Verona, WI is seeking a senior QC leader to oversee the QC Laboratory operations across analytical, microbial, stability, reference standard, and related testing for oligonucleotide and biologics platforms as the site scales to commercial operations.

You will own the QC strategy, manage a multi-manager team, drive inspections readiness, ensure cGMP compliance, and collaborate cross-functionally with Manufacturing, Regulatory, MSAT and Analytical Development to

Qualifications

• 15 years of experience in a GxP pharmaceutical/biotech company or CRO/CMO.
• 7+ years directing QC laboratory operations in a cGMP facility with budget responsibility.
• Master's degree in a scientific field; PhD preferred.

Responsibilities

• Lead QC Laboratory operations, setting vision, strategy, and annual budgets.
• Manage a team of technical staff and managers, including hiring and development.
• Serve as accountable QC owner for PAI readiness and PPQ support; ensure data integrity and CAPA closure.

Skills

People leadership

QC laboratory operations

GxP compliance

Budget management

FDA PAI experience

Education

Master's degree in a scientific field

PhD preferred

Tools

cGMP systems

Job description

Arrowhead Pharmaceuticals, Inc. in Verona, WI is seeking a senior QC leader to oversee the QC Laboratory operations across analytical, microbial, stability, reference standard, and related testing for oligonucleotide and biologics platforms as the site scales to commercial operations.

You will own the QC strategy, manage a multi-manager team, drive inspections readiness, ensure cGMP compliance, and collaborate cross-functionally with Manufacturing, Regulatory, MSAT and Analytical Development to