Manager/ QA Associate, GxP Quality Systems

Company

Ionis develops RNA-targeted medicines and gene-editing approaches for patients with serious diseases.

What you will do

• Support QMS processes and workflows to maintain alignment with regulatory requirements, GMP and GxP expectations, policies, and SOPs.
• Generate, trend, and present quality system metrics while identifying compliance risks, performance gaps, and improvement opportunities.
• Lead and participate in cross-functional initiatives that improve quality system compliance, inspection readiness, and operational efficiency.
• Support Quality Management Reviews through data analysis, presentation materials, action tracking, and follow-up.
• Coordinate inspection readiness activities, including preparation, review of support materials, response tracking, and regulatory commitment follow-up.
• Support supplier, CMO, CTL, internal, and vendor change-management audit activities.

Requirements

• Bachelor’s degree in a science-related or relevant discipline.
• 3+ years of relevant experience in quality assurance or quality management.
• Strong understanding of quality systems guidelines and regulatory requirements in the pharmaceutical or biotechnology industry.
• Strong written and verbal communication, customer orientation, and pragmatic problem-solving skills.

Nice to have

• Familiarity with artificial intelligence applications in a GxP quality assurance or quality systems environment.

Culture & Benefits

• Work environment focused on innovation, scientific excellence, and meaningful impact on patient health.
• Opportunities to develop and expand professional skills.
• Excellent benefits package.
• Company offices are located in Carlsbad and Boston in the United States and Dublin in Ireland.