QA Manager, GxP Quality Systems - Hybrid/Remote

Ionis-Pharmaceuticals; Carlsbad (CA); On-site; USD 70,844 - 102,371; Full time

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. is seeking a Manager / QA Associate, GxP Quality Systems to support compliance across Ionis quality systems and ensure alignment with GMP and GxP requirements.

This role will oversee planning, execution and oversight of QA activities for regulatory readiness. You will lead QMS processes, generate metrics for management, and collaborate with cross-functional teams to strengthen quality system compliance.

Qualifications

• Bachelor’s degree in science-related discipline required.
• 3+ years of relevant QA experience.
• Strong understanding of quality systems guidelines and regulatory requirements in pharma/biotech.
• Familiarity with AI applications in GxP QA is desirable.
• Strong customer orientation and communication skills.

Responsibilities

• Support QMS processes to align procedures with regulatory requirements, GMP and GxP expectations, and Ionis SOPs.
• Generate, trend, and present QMS metrics to management and stakeholders; identify risks and gaps.
• Lead cross-functional initiatives to strengthen quality system compliance and inspection readiness.
• Support Quality Management Review activities, including data collection, analysis, and action follow-up.
• Coordinate inspection readiness efforts and review of support materials; track regulatory commitments.
• Assist in vendor management program activities including supplier audits and change notifications.
• Contribute to new quality initiatives and company-wide projects requiring QA partnership.
• Help design and implement corporate quality and continuous improvement programs.

Skills

Quality Assurance

Regulatory Knowledge

GxP

Communication

Education

Bachelor's degree in science or related discipline

Job description

Ionis Pharmaceuticals, Inc. is seeking a Manager / QA Associate, GxP Quality Systems to support compliance across Ionis quality systems and ensure alignment with GMP and GxP requirements.

This role will oversee planning, execution and oversight of QA activities for regulatory readiness. You will lead QMS processes, generate metrics for management, and collaborate with cross-functional teams to strengthen quality system compliance.