Senior GMP Quality Manager, Drug Substance

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); Hybrid; USD 71,000 - 127,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. is seeking a Manager/Senior Manager, GMP Quality - Drug Substance to lead QA activities for both clinical and limited commercial DS operations.

Onsite in Carlsbad, CA, you will provide strategic leadership, oversee QA processes, and collaborate with CMOs/CDMOs to ensure compliance and inspection readiness. The role requires 5+ years in pharmaceutical QA within a cGMP environment, strong communication, and experience with SAP/Veeva.

Qualifications

• Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or a related discipline.
• At least 5 years of pharmaceutical industry experience, including QA within a cGMP environment.
• Experience working with CMOs/CDMOs, including oversight of manufacturing, testing, and release activities.
• Knowledge of global cGMP regulations (FDA, EMA, ICH, etc.).
• SAP and Veeva systems experience.
• Strong analytical, technical, and communication skills.

Responsibilities

• Lead GMP Quality Assurance activities supporting Drug Substance manufacturing, testing, and release.
• Mentor QA staff and provide functional leadership to matrixed teams.
• Ensure phase-appropriate compliance and inspection readiness across programs.
• Oversee core QMS processes: deviations, CAPAs, change control, OOS/OOT, validation, training.
• Interface with CMOs/CDMOs and approve manufacturing documentation and data.
• Support regulatory inspections and partner audits.

Skills

Analytical thinking

Technical skills

Critical thinking

Written and verbal communication

Education

Bachelor’s degree in Chemistry/Biology/Engineering

Tools

SAP

Veeva

Job description

Ionis Pharmaceuticals, Inc. is seeking a Manager/Senior Manager, GMP Quality - Drug Substance to lead QA activities for both clinical and limited commercial DS operations.

Onsite in Carlsbad, CA, you will provide strategic leadership, oversee QA processes, and collaborate with CMOs/CDMOs to ensure compliance and inspection readiness. The role requires 5+ years in pharmaceutical QA within a cGMP environment, strong communication, and experience with SAP/Veeva.