Quality & Compliance
Senior Auditor, Quality Assurance
Office Location: Verona, WI
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
Serve as a key contributor to the Quality Management System (QMS) by supporting the management and execution of comprehensive internal and external audit programs. This position requires expertise in quality management systems and regulatory compliance to ensure audit activities are executed in accordance with global GxP regulations, company policies, and industry standards. This role plays an integral part in upholding Arrowhead Pharmaceutical’s commitment to patient safety, product quality, and regulatory compliance by partnering with cross-functional teams, external collaborators, and regulatory authorities to drive continuous improvement and maintain a culture of compliance and quality.
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.
Requirements:
- Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Biology, or related discipline.
- 5 years in Quality Assurance or GxP-regulated operations (pharmaceutical, biotechnology, or related industry).
- Strong knowledge of GxP regulations and global compliance expectations.
- Deep expertise and understanding of quality management systems, auditing principles, and risk identification and mitigation.
- Excellent interpersonal and communication skills, with the ability to influence and work within a matrixed environment
- Strong critical thinking, problem-solving, and conflict resolution capabilities.
- Prior experience with use of an electronic management system in a regulated environment.
Preferred
- Professional auditor certification preferred (ASQ CQA, ISO 19011, IRCA Lead Auditor, or equivalent)
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.