Remote Development Quality Assurance Manager (GCP/QMS)

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); Remote; USD 77,000 - 131,000; Full time

Benefits offered by this job

Health benefits

Remote work options

Job summary

Ionis Pharmaceuticals, Inc. seeks a Manager/Senior Manager, Development Quality Assurance to oversee Development controlled documents within Veeva QMS and to guide deviations, CAPAs, and QMS activities.

You will monitor metrics, prepare QMR materials, and support inspections in a fast-paced biotech setting. The role emphasizes quality oversight, document lifecycle management, and cross-functional collaboration with Development teams across geographies.

Qualifications

• Bachelor’s degree with at least 5 years of GCP QA experience.
• Knowledge of ICH/GCP requirements and GxP principles.
• Experience with Veeva Quality or similar QMS platforms.

Responsibilities

• Provide quality oversight for Development controlled documents in Veeva Quality.
• Perform document quality reviews for clarity and compliance with requirements.
• Support deviations, CAPAs, effectiveness checks, and QMS processes.
• Monitor Development QMS metrics and prepare QMS reports for QMR meetings.
• Conduct CSR and TMF audits and support related audits.
• Assist with Health Authority inspections as assigned.

Skills

GCP QA

ICH Guidelines

SOP Writing

GxP Knowledge

Audit Experience

Team Collaboration

Education

Bachelor's degree

Tools

Veeva QMS

Electronic QMS

Job description

Ionis Pharmaceuticals, Inc. seeks a Manager/Senior Manager, Development Quality Assurance to oversee Development controlled documents within Veeva QMS and to guide deviations, CAPAs, and QMS activities.

You will monitor metrics, prepare QMR materials, and support inspections in a fast-paced biotech setting. The role emphasizes quality oversight, document lifecycle management, and cross-functional collaboration with Development teams across geographies.