Remote Development Quality Assurance Manager – QMS Lead

Ionis Pharmaceuticals, Inc.

Northern (KY)

Hybrid

USD 77,000 - 131,000

Full time

5 days ago

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Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. is seeking a Manager/Senior Manager, Development Quality Assurance to provide quality oversight of Development documents in Veeva QMS, ensuring compliance with global regulations.

The role supports deviations, CAPAs, effectiveness checks, and prepares metrics for biannual QMR, along with audits of CSRs and TMF, and potential HA inspections. Remote work options available to collaborate across geographies.

Qualifications

5+ years of GCP quality assurance experience or equivalent.
Strong knowledge of clinical development, ICH guidelines and global GCP requirements.
Experience writing/reviewing SOPs supporting clinical research.
Experience with GCP audits, document and TMF audits.
Experience with electronic QMS, preferably Veeva Quality.

Responsibilities

Provide quality oversight for Development controlled documents within Veeva Quality.
Perform document quality reviews ensuring clarity and compliance with Ionis standards.
Guide Development stakeholders on controlled document requirements and lifecycle activities.
Support continuous improvement of Development QMS processes and tools.
Author/revise Development QA procedures/templates/tools; assist with deviations and CAPAs.
Monitor Development QMS metrics and report for biannual QMR.
Conduct CSR and TMF audits as assigned.
Support Health Authority inspections planning and follow-up.