Manager/Senior Manager, GMP Quality - Drug Substance
Ionis Pharmaceuticals, Inc.
June 30, 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.
Responsibilities
- Lead and manage GMP Quality Assurance activities supporting internal/external Drug Substance and Intermediate manufacturing, testing, and release.
- Provide QA oversight across clinical and commercial programs; ensure phase-appropriate compliance and inspection readiness.
- Oversee and execute core 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, including review/approval of 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 and approve technical/quality documentation (validation reports, stability data, APQR/QMR inputs).
- Utilize enterprise quality systems (SAP and Veeva) and drive continuous improvement.
- Collaborate cross-functionally with Technical Operations, CMC, Regulatory, Clinical, Supply Chain, and IT.
Requirements
- Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or related field.
- 5+ years pharmaceutical industry experience, including Quality Assurance within a cGMP environment.
- Experience supporting DS manufacturing (clinical; limited commercial experience a plus).
- Experience with CMOs/CDMOs, including oversight of manufacturing, testing, and release.
- Working knowledge of global cGMP regulations (FDA, EMA, ICH, etc.).
- SAP and Veeva experience highly desired.
- Strong analytical, technical, critical-thinking, and communication skills; ability to manage multiple priorities.
Preferred/Benefits (if applicable)
- Pay scale: $70,844 to $126,585 (Manager: $70,844 to $102,371; Senior Manager: $87,530 to $126,585)
Application
Apply at http://www.ionis.com; reference requisition #IONIS004028.
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.
Responsibilities
- Lead and manage GMP Quality Assurance activities supporting internal/external Drug Substance and Intermediate manufacturing, testing, and release.
- Provide QA oversight across clinical and commercial programs; ensure phase-appropriate compliance and inspection readiness.
- Oversee and execute core 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, including review/approval of 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 and approve technical/quality documentation (validation reports, stability data, APQR/QMR inputs).
- Utilize enterprise quality systems (SAP and Veeva) and drive continuous improvement.
- Collaborate cross-functionally with Technical Operations, CMC, Regulatory, Clinical, Supply Chain, and IT.
Requirements
- Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or related field.
- 5+ years pharmaceutical industry experience, including Quality Assurance within a cGMP environment.
- Experience supporting DS manufacturing (clinical; limited commercial experience a plus).
- Experience with CMOs/CDMOs, including oversight of manufacturing, testing, and release.
- Working knowledge of global cGMP regulations (FDA, EMA, ICH, etc.).
- SAP and Veeva experience highly desired.
- Strong analytical, technical, critical-thinking, and communication skills; ability to manage multiple priorities.
Preferred/Benefits (if applicable)
- Pay scale: $70,844 to $126,585 (Manager: $70,844 to $102,371; Senior Manager: $87,530 to $126,585)
Application
Apply at http://www.ionis.com; reference requisition #IONIS004028.