Senior GMP Quality Manager - Drug Substance

Xtalks; Carlsbad (CA); On-site; USD 71,000 - 127,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. is seeking an experienced Manager/Senior Manager, GMP Quality - Drug Substance to lead QA activities for DS manufacturing and testing.

You will provide strategic leadership, ensure compliance and inspection readiness, and partner with CMOs across clinical and limited commercial programs. The role requires deep cGMP knowledge, collaboration across Technical Operations, Regulatory, and Supply Chain, and hands-on QA expertise to drive quality and process improvements

Qualifications

• Bachelor's degree in a related discipline.
• 5+ years in pharma QA within a cGMP environment.
• Experience with Drug Substance manufacturing and CMOs/CDMOs.
• Knowledge of global cGMP regulations (FDA/EMA/ICH).
• Experience with SAP and Veeva systems.
• Strong analytical, technical and communication skills.

Responsibilities

• Lead GMP QA activities for Drug Substance manufacturing, testing and release.
• Mentor QA staff and provide functional leadership in matrix teams.
• Ensure phase-appropriate compliance and inspection readiness.
• Oversee QMS processes including deviations, CAPAs and change control.
• Interface with CMOs/CDMOs and review documentation and data.
• Support regulatory inspections and audits, and QP interactions.
• Review validation reports, stability data and APQR/QMR inputs.
• Utilize SAP and Veeva to support compliant quality operations.
• Drive continuous improvement for compliance and product quality.
• Collaborate cross-functionally with Technical Ops, Regulatory, Clinical, Supply Chain and IT.

Skills

Quality Assurance

cGMP expertise

Regulatory knowledge

Cross-functional collaboration

Strong communication

Education

Bachelor's degree in Chemistry, Biology, Engineering or related

Tools

SAP

Veeva

Job description

Ionis Pharmaceuticals, Inc. is seeking an experienced Manager/Senior Manager, GMP Quality - Drug Substance to lead QA activities for DS manufacturing and testing.

You will provide strategic leadership, ensure compliance and inspection readiness, and partner with CMOs across clinical and limited commercial programs. The role requires deep cGMP knowledge, collaboration across Technical Operations, Regulatory, and Supply Chain, and hands-on QA expertise to drive quality and process improvements