Arrowhead Pharmaceuticals · 4 hours ago
Vice President, Quality
Verona, Wisconsin, United States
Full-time
Onsite
Director/Executive
$280K/yr - $340K/yr
15+ years expArrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for genetic diseases. The Vice President, Quality is responsible for providing quality leadership, overseeing quality systems, and ensuring compliance with regulatory requirements across the organization.
BiotechnologyHealth CareNanotechnologyPharmaceutical
No H1B
Responsibilities
Develop and facilitate Quality Systems as delineated in the Quality Manual to support Arrowhead’s clinical development pipeline and preparations for product commercialization
Implement and maintain an overall Quality Management System (QMS) meeting the requirements of activities conducted within Arrowhead
Develop and oversee the internal Quality Control (QC) lab department and operations
Support activities relating to clinical QA GCP regulations at the Pasadena location
Ensure systems are in place for conducting and tracking employee training required by GxP regulations
Support efforts pertaining to internal design, construction, commissioning, and qualification of GMP facilities
Review and approve outsourced contract manufacturing documentation such as validation protocols and reports; master batch records; deviations; analytical methods and methods validation; executed batch documentation; labels; and packaging records
Maintain a system for qualification of GxP vendors and coordinate auditing of GxP vendors
Ensure an system for GXP vendor qualification
Establish Quality Agreements with GMP vendors
Lead development and maintenance of service and supplier vendor qualification programs
Perform investigations into non-conformances and product deviations
Document and determine CAPAs, change controls required for internal cGMP processes as well as oversight of these investigations and corrective actions with external vendors
Implement and maintain a validated document control system, and develop SOPs/Work Instructions (WI) across functional areas impacting GMP, GLP, and GCP
Lead communication and interaction with Qualified Person (QP) to support investigational and commercial product supply chain in Europe
Participate in hosting audits or inspections of Arrowhead’s QMS by regulatory agencies, development partners and licensees
Participate in the established review cycle of QA controlled documents and GxP procedures to assure practices reflect written procedures
Keep supervisor abreast of significant issues or developments identified during quality activities, as well as actions to be taken for continuous improvement of quality systems
Maintain a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GxP regulations
Participate in the establishment and maintenance of an internal system for documentation organization and retention that meets global regulatory requirements and corporate business needs
Lead the annual management review of the overall Quality Management System and associated data
Hiring, development, and leadership of Quality department staff
Qualification
Required
BS in Life Sciences or related discipline
15+ years in QA or compliance with particular experience in cGMP commercial manufacturing environment and with experience in GCP clinical programs for drugs and/or biologics preferred
10+ years in a previous management role
Experience with developing a QMS and hosting successful regulatory agency inspections
Ability to thrive in a fast-paced environment, with experience in sponsor quality oversight responsibilities for contract vendors across all GxP areas
Implementation of internal phase appropriate GMP drug substance manufacturing & testing systems
Prior successful management of a Quality Management System for commercial product
Drug development through commercial manufacturing compliance experience
Excellent oral and written communication skills required
Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint)
Familiarity with electronic document managements systems, Part 11 compliance and electronic document archiving systems
Ability for occasional business travel
Preferred
Advanced degree preferred
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
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
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