Manager​/QA Associate, GxP Quality Systems

Ionis is seeking a Manager / QA Associate, GxP Quality Systems, to support compliance across Ionis quality systems. Responsible for planning, execution, and oversight of GMP and GxP quality assurance activities and alignment with applicable domestic and international regulatory requirements, industry guidelines, and Ionis quality management system procedures.

• Support QMS processes and workflows to ensure procedures, records, and practices align with regulatory requirements, GMP/GxP expectations, and Ionis policies/SOPs.
• Generate, trend, and present QMS metrics; identify compliance risks, performance gaps, and continuous improvement opportunities.
• Lead and participate in cross-functional initiatives to strengthen quality system compliance, effectiveness, inspection readiness, and operational efficiency.
• Support Quality Management Review activities (data collection/analysis, presentation materials, facilitation, action documentation, and follow-up).
• Support inspection readiness (coordination, review of inspection materials, response tracking, follow-up on commitments).
• Support vendor management (supplier/CMO/CTL audit support, internal audit activities, vendor change notifications).
• Support new quality initiatives and company-wide projects requiring QA partnership.
• Contribute to design and implementation of corporate quality and continuous improvement programs.

• Bachelor’s degree in a science-related or other relevant discipline (required).
• Strong understanding of quality assurance/quality management with 3+ years relevant experience (required).
• Strong understanding of quality system guidelines and regulatory requirements for pharma/biotech (required).
• Familiarity with AI applications in a GxP quality assurance/quality systems environment (highly desirable).
• Strong customer orientation; written/verbal communication and pragmatic problem-solving skills (required).

• The pay scale for this position is $70,844 to $102,371.