Arrowhead Pharmaceuticals · 3 hours ago
Manager, Quality Systems
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$130K/yr - $165K/yr
7+ years expArrowhead Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative drugs for genetic diseases. The Information Systems & Informatics Quality Systems Manager is responsible for overseeing and improving enterprise Quality Systems to ensure compliance and support regulated business processes.
BiotechnologyHealth CareNanotechnologyPharmaceutical
Responsibilities
System Owner - manage electronic QMS and processes, including Change Control, Deviations, CAPAs, SCARs, Audits, Findings, Suppliers, Complaints Management, Batch Release Management, Document Management, Training, etc
Ensure systems align with established Quality System procedures and business process requirements
Identify and lead continuous improvement initiatives to enhance system usability, compliance, and efficiency
CSA.CSV expertise
Regulatory Applicability Assessments/Risk assessments
IQ/OQ/PQ documentation
Periodic review
Create and manage system changes through formal change control processes
Ensure proper system configuration, access control, data integrity, and backup/recovery practices
Cross-Functional Collaboration
Partner with business partners to ensure systems effectively support business needs
Act as a subject matter expert (SME) for Quality systems & Processes across the organization
Qualification
Required
Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, or related field
7+ years of experience implementing/supporting GxP-regulated IT systems within pharmaceutical, biotech or equivalent Commercial Operations background
Strong knowledge of Quality Systems and QMS business processes
Hands-on experience with system validation and compliance in regulated environments
In-depth understanding of 21 CFR Part 11, EudraLex Annex 11, and data integrity principles
Experience supporting audits and regulatory inspections
GxP compliance and regulatory knowledge
CSA/CSV expertise
Quality mindset with strong attention to detail
Excellent communication and stakeholder management skills
Ability to balance compliance requirements with business efficiency
Leadership in cross-functional, matrixed environments
Preferred
Direct Veeva Vault Quality administration experience
Experience supporting automation, engineering, commercial manufacturing, quality operations
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
Recent News
2026-01-14
Company data provided by crunchbase