Manager/Senior Manager, GMP Quality - Drug Substance

Summary

Ionis is seeking an experienced Manager/ Senior Manager, GMP Quality - Drug Substance to provide Quality Assurance activities supporting both clinical and commercial Drug Substance (DS) manufacturing and testing. This role provides strategic leadership, operational oversight, and hands-on QA expertise across internal operations and external manufacturing partners.

Responsibilities

• Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing, testing, and release.
• Serve as the QA interface for contract manufacturing and testing organizations (CMOs), including review and approval of manufacturing documentation, analytical data, deviations, changes, and validation packages.
• Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions.
• Review and approve technical and quality documentation, including validation reports, stability data, and APQR/QMR inputs.
• Drive continuous improvement initiatives to enhance compliance, efficiency, and product quality.
• Collaborate cross-functionally with Technical Operations, CMC, Regulatory, Clinical, Supply Chain, and IT teams.
• Communicate quality- or supply-impacting issues clearly to internal and external stakeholders.
• Perform additional duties as assigned.

Requirements

• Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or a related discipline
• At least 5 years of pharmaceutical industry experience, including Quality Assurance within a cGMP environment
• Demonstrated experience supporting Drug Substance manufacturing across both clinical; limited commercial experience is a plus but not required
• Experience working with CMOs/CDMOs, including oversight of manufacturing, testing, and release activities
• Working 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
• Excellent written and verbal communication skills
• Ability to manage multiple priorities and adapt to changing business needs