Assistant Director/Associate Director, GMP Quality – Drug Substance (Clinical & Commercial)
$102k/y-$182k/y
Ionis Pharmaceuticals, Inc.a day ago
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OnsiteFull-timeDirector
Summary
Ionis Pharmaceuticals, Inc. is seeking an experienced Assistant Director/Associate Director, GMP Quality – Drug Substance to lead and oversee Quality Assurance activities supporting both clinical and commercial Drug Substance manufacturing and testing in Carlsbad, CA.
About the Role
As the Assistant Director/Associate Director, GMP Quality, you will provide strategic quality leadership across Ionis’ Drug Substance portfolio, ensuring compliance and inspection readiness. You will manage GMP Quality Assurance activities, mentor QA staff, drive continuous improvement initiatives, and collaborate with cross-functional teams. This role requires oversight of core Quality Management System processes and participation in regulatory inspections.
About You
Required:
- Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or a related discipline (advanced degree preferred).
- 10–12+ years of pharmaceutical industry experience, including 7–8+ years in Quality Assurance within a cGMP environment.
- Demonstrated experience supporting Drug Substance manufacturing across both clinical and commercial stages.
Preferred:
- Strong knowledge of global cGMP regulations (FDA, EMA, ICH, etc.).
- Experience with SAP and Veeva systems.
- Strong analytical, technical, and critical-thinking skills with experience in manufacturing.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and adapt to changing business needs.
Benefits
- Highly competitive benefits package including medical, dental, and vision coverage.
- Opportunities for professional development and career advancement.
Ionis Pharmaceuticals, Inc.
For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis currently has five marketed medicines and a leading pipeline in neurology, cardiology, and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients.
Carlsbad, CA