Senior QA Change Leader, Pharma QMS & Risk

American Society for Quality; Verona, Northern (WI, KY); Hybrid; USD 90,000 - 110,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Verona, WI seeks a Senior QA Specialist to support the QMS change management program across preclinical, clinical, and commercial programs.

You will facilitate change requests, coordinate Change Control Board activities, and ensure actions meet regulatory requirements. This role emphasizes risk assessment, cross-functional collaboration, and continuous improvement of QA processes, documentation, and tools within GMP environments.

Qualifications

• Bachelor's degree in a science discipline.
• 5+ years of experience in a regulated environment with QA/change management exposure.
• 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.

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.

Skills

Communication skills

Cross-functional coordination

Regulatory knowledge

Education

Bachelor's degree in science

Tools

Smartsheet

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. in Verona, WI seeks a Senior QA Specialist to support the QMS change management program across preclinical, clinical, and commercial programs.

You will facilitate change requests, coordinate Change Control Board activities, and ensure actions meet regulatory requirements. This role emphasizes risk assessment, cross-functional collaboration, and continuous improvement of QA processes, documentation, and tools within GMP environments.