Manager/Senior Manager, GMP Quality - Drug Substance
Ionis Pharmaceuticals, Inc.
August 12, 2026
Remote friendly (Carlsbad, CA)
United States
Operations
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 DS and Intermediate manufacturing, testing, and release.
- Lead complex cross-functional quality initiatives and influence quality systems and operational strategy; independently manage regulatory inspection activities and high-risk quality decisions.
- Provide QA oversight across clinical and commercial programs to ensure phase-appropriate compliance and inspection readiness.
- Execute QMS processes: batch record review, deviations, investigations, CAPAs, change control, OOS/OOT management, risk management, validation, and training compliance.
- Serve as QA interface for CMOs/contract manufacturers and testing organizations (review/approve manufacturing documentation, analytical data, deviations, changes, and validation packages).
- Provide real-time QA support and risk-based decision-making during critical manufacturing operations.
- Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions.
- Review/approve technical and quality documentation (validation reports, stability data, APQR/QMR inputs).
- Use enterprise quality systems (SAP, Veeva).
- Drive continuous improvement; collaborate cross-functionally (Technical Operations, CMC, Regulatory, Clinical, Supply Chain, IT); communicate quality/supply-impacting issues.
Requirements
- Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or related discipline.
- At least 5 years of pharmaceutical industry experience, including Quality Assurance within a cGMP environment.
- Demonstrated experience supporting DS manufacturing for clinical programs (limited commercial experience is a plus).
- Experience working with CMOs/CDMOs, including oversight of manufacturing, testing, and release.
- Working knowledge of global cGMP regulations (FDA, EMA, ICH).
- SAP and Veeva experience highly desired.
- Strong analytical/technical/critical-thinking skills; excellent written/verbal communication; ability to manage multiple priorities.
Application
- Apply via http://www.ionis.com; reference requisition #IONIS004028.
Benefits/Pay
- Pay scale: $70,844 to $126,585 (Manager: $70,844 to $102,371; Senior Manager: $87,530 to $126,585).
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 DS and Intermediate manufacturing, testing, and release.
- Lead complex cross-functional quality initiatives and influence quality systems and operational strategy; independently manage regulatory inspection activities and high-risk quality decisions.
- Provide QA oversight across clinical and commercial programs to ensure phase-appropriate compliance and inspection readiness.
- Execute QMS processes: batch record review, deviations, investigations, CAPAs, change control, OOS/OOT management, risk management, validation, and training compliance.
- Serve as QA interface for CMOs/contract manufacturers and testing organizations (review/approve manufacturing documentation, analytical data, deviations, changes, and validation packages).
- Provide real-time QA support and risk-based decision-making during critical manufacturing operations.
- Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions.
- Review/approve technical and quality documentation (validation reports, stability data, APQR/QMR inputs).
- Use enterprise quality systems (SAP, Veeva).
- Drive continuous improvement; collaborate cross-functionally (Technical Operations, CMC, Regulatory, Clinical, Supply Chain, IT); communicate quality/supply-impacting issues.
Requirements
- Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or related discipline.
- At least 5 years of pharmaceutical industry experience, including Quality Assurance within a cGMP environment.
- Demonstrated experience supporting DS manufacturing for clinical programs (limited commercial experience is a plus).
- Experience working with CMOs/CDMOs, including oversight of manufacturing, testing, and release.
- Working knowledge of global cGMP regulations (FDA, EMA, ICH).
- SAP and Veeva experience highly desired.
- Strong analytical/technical/critical-thinking skills; excellent written/verbal communication; ability to manage multiple priorities.
Application
- Apply via http://www.ionis.com; reference requisition #IONIS004028.
Benefits/Pay
- Pay scale: $70,844 to $126,585 (Manager: $70,844 to $102,371; Senior Manager: $87,530 to $126,585).