Arrowhead Pharmaceuticals · 2 weeks ago
Manager, Quality Assurance (GMP External Auditor)
San Diego, California, United States
Full-time
Onsite
Mid, Senior Level
$105K/yr - $125K/yr
5+ years expArrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Manager, Quality Assurance will lead vendor audits and support the vendor qualification management team, ensuring compliance with GxP regulations and managing quality events.
BiotechnologyHealth CareNanotechnologyPharmaceutical
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
Qualification
Required
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
All applicants must have authorization to work in the US for a company
Benefits
Competitive salaries
Excellent benefit package
Company
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals is a biotechnology company that focuses on the development of medicine to treat diseases with a genetic origin.
501-1000 employees
H1B Sponsorship
Arrowhead Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (1)
2022 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.45BKey Investors
Sarepta TherapeuticsSixth StreetSilence Therapeutics
2026-01-07Post Ipo Equity· $200M
2026-01-07Post Ipo Debt· $625M
2024-11-26Post Ipo Equity· $325M
Leadership Team
Christopher Anzalone
President and Chief Executive Officer
Bruce Given
Chief Operating Officer
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase