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Arrowhead Pharmaceuticals · 10 hours ago

Senior Auditor, Quality Assurance

Verona, WI

Full-time

Onsite

Mid, Senior Level

$85K/yr - $100K/yr

5+ years exp

Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Senior Auditor, Quality Assurance will support the Quality Management System by managing internal and external audit programs, ensuring compliance with GxP regulations, and driving continuous improvement across the organization.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Develop, implement, and maintain a comprehensive internal audit program covering applicable company objectives and global GxP requirements including GMP (FDA, EMA, ICH, MHRA, etc.), ICH guidelines, and ISO standards across Arrowhead facilities and operations

Create risk-based audit plans and schedules and maintain oversight of planning, coordination, and execution per the established audit plans

Prepare and issue comprehensive audit reports that clearly identify compliance gaps, systemic risks, and areas for improvement

Coordinate and support regulatory inspections by FDA, EMA, and other health authorities, ensuring inspection readiness and effective responses to regulatory queries

Conduct inspection readiness assessments and mock inspections to prepare facilities and teams for regulatory scrutiny

Communicate audit findings to applicable quality leadership and facilitate timely escalation and resolution

Coordinate audit response activities and maintain oversight to ensure regulatory compliance and effective follow-up through to closure

Coordinate with cross-functional teams to implement process improvements and preventive measures based on audit observations

Oversee corrective and preventive actions (CAPAs) CAPA activities resulting from internal audits and external inspections to ensure timely and effective closure

Track audit findings, trends, and metrics to identify systematic issues and opportunities for improvements initiatives

Mentor and train other team members on audit methodologies and best practices

Other duties as assigned

Qualification

Quality Management SystemsGxP RegulationsAuditing PrinciplesRisk IdentificationRegulatory ComplianceProfessional Auditor CertificationElectronic Management SystemInterpersonal SkillsProblem-SolvingConflict Resolution