GMP Quality Lead, Drug Substance – Manager/Senior

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

Benefits offered by this job

Benefits package

Job summary

Ionis Pharmaceuticals in Carlsbad, CA seeks a Manager/Senior Manager, GMP Quality - Drug Substance to provide QA leadership across internal and external DS manufacturing and testing. Reference is made to phase-appropriate compliance, QMS processes, and collaboration with CMOs/CDMOs.

The role emphasizes supporting regulatory inspections, document reviews and cross-functional partnership to ensure product quality and compliance.

Qualifications

• Bachelors in Chemistry, Biological Sciences, Engineering or related field.
• Strong analytical, technical and critical-thinking abilities.
• Excellent written and verbal communication skills.

Responsibilities

• Lead GMP Quality Assurance activities for Drug Substance manufacturing, testing and release.
• Provide QA oversight for clinical and commercial programs with risk-based focus.
• Support QMS processes: deviations, CAPAs, change control, investigations, and validation.
• Collaborate with CMOs/CDMOs and review manufacturing/analytical documentation.
• Assist in regulatory inspections and partner audits; ensure compliance.

Skills

Analytical skills

Communication skills

Critical thinking

Education

Bachelor’s degree in Chemistry/Biological Sciences/Engineering

Tools

SAP

Veeva

Job description

Ionis Pharmaceuticals in Carlsbad, CA seeks a Manager/Senior Manager, GMP Quality - Drug Substance to provide QA leadership across internal and external DS manufacturing and testing. Reference is made to phase-appropriate compliance, QMS processes, and collaboration with CMOs/CDMOs.

The role emphasizes supporting regulatory inspections, document reviews and cross-functional partnership to ensure product quality and compliance.