Senior Manager, Development QA & QMS (Remote)

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

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals is seeking a Manager/Senior Manager, Development Quality Assurance to provide quality oversight for Development controlled documents in Veeva QMS, perform document quality reviews, and guide stakeholders on templates, lifecycle activities and CAPAs. The role supports monthly metrics and coordination for global inspections.

Qualified candidates have a bachelor’s degree with 5+ years in GCP QA, strong ICH/GCP knowledge, and experience with SOPs, audits and TMF/CSR.

Qualifications

• Bachelor's degree required with 5+ years of GCP QA experience.
• Strong knowledge of clinical development, ICH guidelines and global GCP requirements.
• Experience with SOPs, audits (GCP, TMF/CSR) and electronic QMS platforms.
• Ability to manage controlled documents lifecycle and quality reviews.

Responsibilities

• Provide quality oversight for Development controlled documents in Veeva Quality.
• Perform document quality reviews for clarity, compliance and consistency.
• Guide Development stakeholders on workflows, templates and lifecycle activities.
• Support QMS processes, templates/tools and CAPA activities.

Skills

GCP quality assurance

ICH Guidelines

Quality oversight

Deviations & CAPAs

QMS metrics

Audit support

Education

Bachelor's degree

Tools

Veeva Quality

Job description

Ionis Pharmaceuticals is seeking a Manager/Senior Manager, Development Quality Assurance to provide quality oversight for Development controlled documents in Veeva QMS, perform document quality reviews, and guide stakeholders on templates, lifecycle activities and CAPAs. The role supports monthly metrics and coordination for global inspections.

Qualified candidates have a bachelor’s degree with 5+ years in GCP QA, strong ICH/GCP knowledge, and experience with SOPs, audits and TMF/CSR.