Senior Manager, QMS Programs

Arrowhead Pharmaceuticals•Verona, WI

7d•$150,000 - $165,000•Onsite

About The Position

Arrowhead Pharmaceuticals is seeking a Senior Manager, QMS Programs to drive continuous improvement of the systems, processes, and functions that comprise its GxP Quality Management System. The role ensures compliance with regulatory requirements, industry standards, and company policies in support of the development, manufacturing, testing, release, and distribution of clinical and commercial pharmaceutical and device products. The position provides expertise on quality systems and associated processes across the regulated environment and coordinates audit and inspection activities, including internal audits, partner audits, and regulatory health authority inspections. This is a full-time onsite position, five days a week, in Verona, Wisconsin. The role works cross-functionally to improve quality systems and compliance programs, support inspection readiness, and foster a culture of quality, collaboration, and accountability.

Requirements

Bachelor's degree in life sciences, pharmacy, chemistry, or a related field.
At least eight years of experience in the regulated pharmaceutical and/or biotechnology industry, including at least five years 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 project management, organization, execution, and priority-setting skills.
Proven experience developing and/or improving QMS, QE, and compliance programs.
Strategic thinking, motivation, and a focus on continuous improvement and innovation, including the ability to anticipate and resolve problems.
Excellent communication, interpersonal, and leadership skills, with the ability to work with diverse professionals and influence stakeholders at all levels.
Previous experience using electronic document and quality management systems (EMDS/EQMS).
Ability to travel occasionally.
Ability to work onsite five days per week in Verona, WI.
Current, valid authorization to work in the country where the role is located.

Nice To Haves

Advanced degree in a science field.

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 lead internal audits, including preparation, execution, response coordination, and follow-up of observations.
Coordinate partner audits, including preparation, hosting, response development, and oversight of commitments and CAPAs.
Coordinate and support regulatory health authority inspection readiness, including GMP and GDP logistics planning, inspection hosting, and support.
Develop, review, and approve controlled documents in alignment with regulatory requirements, relevant guidance, and company standards.
Facilitate quality management reviews and support the development of registers, KPIs, metrics, dashboards, and routine reporting mechanisms.
Apply project management and execution methodologies to prioritize, plan, and deliver quality system and compliance initiatives 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.