Arrowhead Pharmaceuticals · 18 hours ago
Senior Manager, QMS Programs
Verona, Wisconsin, United States
Full-time
Onsite
Senior Level, Lead/Staff
$145K/yr - $165K/yr
8+ years expArrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Senior Manager, QMS Programs will drive cross-functional improvement initiatives for the GxP Quality Management System while ensuring compliance with regulatory requirements and industry standards.
BiotechnologyHealth CareNanotechnologyPharmaceutical
No H1B
Responsibilities
Identify, champion, and drive cross-functional improvement initiatives to enhance and streamline quality systems, frameworks, and associated processes
Facilitate stakeholder engagement to ensure quality systems are continuously monitored and improved to strengthen compliance and operational efficiency
Plan, coordinate, and participate in internal audit activities, including preparation, execution, response coordination, and follow-up of observations
Coordinate partner audit activities, including preparing, hosting, coordinating response development, and overseeing commitments and CAPAs
Coordinate and support regulatory health authority inspection readiness efforts (e.g., GMP, GDP), including logistics planning and inspection hosting support
Develop, review, and approve a variety of controlled documents in alignment with regulatory requirements, relevant guidance, and company standards
Facilitate quality management reviews and support the development of registers, KPIs, metrics, and dashboards as well as mechanisms for routine reporting
Apply project management and execution methodologies to prioritize, plan, and deliver quality system and compliance initiatives in collaboration with stakeholders
Monitor evolving regulatory requirements and guidance, and partner with stakeholders to assess and address potential impacts to the quality system
Foster a culture of quality, collaboration, and accountability within the team and across the organization
Perform additional duties as requested
Qualification
Required
Bachelor's degree in life sciences, pharmacy, chemistry, or related field
8+ years of experience in the regulated pharmaceutical and/or biotechnology industry, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility
Full knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards
Demonstrated skills in the areas of project management, organization, and execution as well as priority setting
Proven experience developing and/or improving QMS, QE, and compliance programs
Highly motivated, strategic thinker with a focus on continuous improvement and innovation, who endeavors to anticipate and resolve problems
Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels
Previous experience with the use of electronic document / quality management systems (EMDS / EQMS)
Ability for occasional business travel
Preferred
Additional Quality/Regulatory related certification desired, such as CQA, CQMP, RAC, etc
Advanced degree in life science
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
Company data provided by crunchbase