Senior GMP Quality Lead, Drug Substance

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

Benefits offered by this job

Full benefits package

Onsite work in Carlsbad

Job summary

Ionis is seeking an experienced Manager/Senior Manager, GMP Quality - Drug Substance to provide Quality Assurance leadership across internal and external Drug Substance manufacturing, testing, and release. You will mentor QA staff, ensure phase-appropriate compliance, and support inspections.

Onsite in Carlsbad, CA, with a strong focus on cGMP, regulatory readiness, and cross-functional collaboration with Technical Operations, Regulatory, and CMOs. Competitive benefits offered.

Qualifications

• Bachelor’s degree required in Chemistry, Biological Sciences, Engineering, or a related discipline.
• Strong analytical, technical, and communication skills.
• Ability to manage multiple priorities in a cGMP environment.

Responsibilities

• Lead GMP Quality Assurance activities for Drug Substance manufacturing, testing, release.
• Provide QA oversight across clinical and commercial programs and external CMOs.
• Support regulatory inspections, partner audits, and QP interactions.
• Maintain compliance with SAP and Veeva systems for QA operations.

Job description

Ionis is seeking an experienced Manager/Senior Manager, GMP Quality - Drug Substance to provide Quality Assurance leadership across internal and external Drug Substance manufacturing, testing, and release. You will mentor QA staff, ensure phase-appropriate compliance, and support inspections.

Onsite in Carlsbad, CA, with a strong focus on cGMP, regulatory readiness, and cross-functional collaboration with Technical Operations, Regulatory, and CMOs. Competitive benefits offered.