The PositionWork cross-functionally to drive and champion projects related to continuous improvement of the systems, processes, and functions comprising the GxP Quality Management System (QMS), while ensuring compliance with regulatory requirements, industry standards, and company policies in support of the development, manufacturing, testing, release, and distribution of pharmaceutical and device products (clinical and commercial). Provide expertise on the quality systems and associated processes operating across the regulated environment. Coordinate and guide audit and inspection activities, including internal audits, partner audits, and regulatory health authority inspections.
This role is full-time onsite, 5 days a week in Verona, WI.
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 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 and 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.
Requirements- Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
- Minimum of eight (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
- Advanced degree in a science field.
Wisconsin pay range
$150,000-$165,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
