Lead Supplier Auditor

Arrowhead Pharmaceuticals; Pasadena (CA); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefit package

Job summary

A leading biopharmaceutical firm in Pasadena is seeking an experienced individual to manage vendor audits. The role requires conducting independent audits, ensuring compliance with GxP regulations, and maintaining audit documentation. Candidates must have a Bachelor's degree in a science discipline and 5 years of relevant GxP auditing experience. Knowledge of FDA regulations and strong communication skills are essential. This role offers a competitive salary and excellent benefits, with travel required for inspections.

Qualifications

• 5 years of relevant experience in GxP auditing and compliance.
• Strong knowledge of GMP/GLP/GDP/GCP/GVP and FDA regulations.
• Prior experience in compliance investigation is advantageous.

Responsibilities

• Conduct vendor audits and internal system audits independently.
• Assist in generating and tracking quality metrics.
• Facilitate quality improvement and communicate audit results.

Skills

GxP auditing

Quality improvement

Compliance communication

Data integrity audits

Education

Bachelor’s degree in a science discipline

Tools

Veeva electronic repositories

Job description

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.