Manager/ Senior Manager, Development Quality Assurance

Role: Manager/Senior Manager, Development Quality Assurance at Ionis, overseeing quality processes for controlled documents within the Veeva QMS to ensure compliance with global GxP regulations in drug development. Responsibilities include managing document lifecycle activities, performing document reviews, supporting deviations and CAPAs, monitoring QMS metrics, and preparing reports for biannual QMR meetings. The role involves conducting GCP audits such as CSR and TMF audits, supporting Health Authority inspections, and promoting continuous improvement of QMS processes. Requirements: Bachelor’s degree with ≥5 years GCP QA experience or equivalent, strong knowledge of clinical development, ICH GCP guidelines, and global GxP standards; experience with electronic QMS platforms (preferably Veeva Quality). Preferred: healthcare/scientific background, experience in writing SOPs, and managing controlled document activities. High-value biopharma specifics: focus on clinical GCP compliance, audits, document management, and regulatory inspection support. Position is remote with potential for travel, requiring effective cross-functional collaboration and meticulous attention to detail.