Quality Assurance Manager (External GxP Auditor) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Arrowhead Pharmaceuticals · 7 hours ago

Quality Assurance Manager (External GxP Auditor)

positionSan Diego, CA
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$105K/yr - $125K/yr
date5+ years exp

Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative drugs for genetic diseases. The Quality Assurance Manager will lead vendor audits in accordance with GxP regulations, support vendor qualification management, and assist with quality events and inspection readiness.

BiotechnologyHealth CareNanotechnologyPharmaceutical
check
Comp. & BenefitsbadNo H1Bnote

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

GxP auditingGMP/GLP/GDP/GCP/GVP knowledgeFDA regulationsComputer System ValidationData integrity auditsBachelor’s degreeQuality improvementCommunication skills

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

Benefits

Competitive salaries
An excellent benefit package

Company

Arrowhead Pharmaceuticals

twittertwittertwitter
company-logo
Arrowhead Pharmaceuticals is a biotechnology company that focuses on the development of medicine to treat diseases with a genetic origin.
dateFounded in 1989
location
Pasadena, California, USA
people-size501-1000 employees
web-link
http://arrowheadpharma.com/

Funding

Current Stage
Public Company
Total Funding
$2.45B
Key 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

leader-logo
Christopher Anzalone
President and Chief Executive Officer

Recent News

BioSpace
4 Next-Gen Candidates That Could Form the Future of Alzheimer’s Treatment
2026-01-19
BioSpace
After Mortality-Marred Year, Sarepta Looks Ahead to Catalyst-Rich 2026
2026-01-14
FiercePharma
2025 drug approvals: Despite FDA tumult and macro uncertainty, biopharma scored with 55 new products
2026-01-09
Company data provided by crunchbase