Assistant Director/Associate Director, GMP Quality – Drug Substance (Clinical & Commercial)

Ionis 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 (DS) manufacturing and testing. The successful candidate will serve as a key Quality partner to Technical Operations and external manufacturing and testing organizations, with direct influence on inspection readiness, product supply, and lifecycle execution.

Requirements

• 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
• Strong knowledge of global cGMP regulations (FDA, EMA, ICH, etc.)
• Experience with SAP and Veeva systems is highly desired
• Strong analytical, technical, and critical-thinking skills with experience in manufacturing is preferred
• Excellent written and verbal communication skills
• Ability to manage multiple priorities and adapt to changing business needs

Benefits

• Generous Paid Time Off
• 401k Matching
• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance