The PositionThis position serves as a individual contributor within the Quality Assurance department, supporting the change management process within the Quality Management System (QMS) for Arrowhead's preclinical, clinical, and commercial programs. The role will support change control activities for regulated processes and systems, equipment and instruments, computerized systems, products and specifications, manufacturing processes, analytical methods, suppliers, and related regulatory documentation. This includes supporting risk assessment activities performed as part of the change management process. The Senior QA Specialist partners with internal departments and cross-functional teams to ensure proposed changes are appropriately assessed for impact, implemented in a controlled manner, and verified for effectiveness.
Responsibilities
- Support assigned components of the QMS change control system, including facilitating the review, processing, and disposition of change requests for completeness, accuracy, and procedural compliance.
- Coordinate and support Change Control Board (CCB) meetings, including agenda preparation, minutes, and tracking of follow-up action items to closure.
- Support cross-functional assessments of proposed changes, working with stakeholders to evaluate impact and confirm appropriate action plans and effectiveness checks are established and completed.
- Support risk assessment activities conducted as part of the change management process, partnering with cross-functional stakeholders to identify, evaluate, and document quality and compliance risks associated with proposed changes.
- Maintain and update CCB schedules and dashboards for the QMS and specified functional areas.
- Conduct quality review and disposition of change controls and effectiveness checks for accuracy, completeness, and alignment with regulatory requirements and business needs prior to escalation for approval.
- Compile metrics and prepare reports on change management activities for review boards and in support of annual product quality reviews.
- Train and coach stakeholders on change management processes within the QMS to promote consistency and drive quality culture.
- Support internal audits, regulatory inspections, and third-party audits as a subject matter resource for change management processes.
- Drive continuous improvement of QMS processes, documentation, tools, and workflows related to change management.
- Writing, review, change control, approval, issuance, and organization of applicable procedural documents (such as policies, SOPs, work instructions, or forms) utilizing existing templates.
- Additional duties as assigned.
Requirements- Minimum of a bachelor's degree in a science discipline, or equivalent required.
- Minimum of five (5) years of experience working in a regulated environment, with preference to quality assurance, change management, and/or risk management experience or equivalent required.
- Working knowledge of FDA, EU, and ICH GxP regulations and guidance.
- Excellent written and verbal communication skills and ability to communicate effectively with internal and external parties.
- Demonstrated ability to coordinate cross-functional activities and drive tasks to completion.
- Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.
Preferred- Ability to work independently and manage priorities within a fast-paced environment.
- Demonstrated ability to coordinate cross-functional activities and drive tasks to completion.
- Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, QMSR, and EU GMP).
- Prior experience with use of an electronic document and quality management system in a regulated environment
Wisconsin pay range
$90,000-$110,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
