Quality & Compliance
Quality Assurance GxP Auditor
Office Location: Pasadena, CA or San Diego, CA
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
This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness.
Responsibilities
- Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses
- Assist in generation, tracking, monitoring, and reporting of key quality metrics
- Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams
- Support health authority inspections
- Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings)
- Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations.
- Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs)
- Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures
- Work with Vendor Management Teams on identifying and mitigating any compliance issues
- Oversee contract auditors and others perform audits on behalf of Arrowhead
- Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories
- Other duties consistent with the position as assigned from time to time
Requirements:
- Bachelor’s degree in a science discipline is required.
- 5 years of relevant experience in GxP auditing and compliance
- Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines
- Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience
- Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial
- Requires travel to other Arrowhead locations as well as domestic and international travel
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.