Manager / Senior Manager, Development Quality Assurance (Veeva)

Location: Remote

Salary: $77,218–$130,560 annually. Manager range: $77,218–$104,500; Senior Manager range: $93,805–$130,560.

Company

Ionis is a pharmaceutical company developing RNA-targeted medicines, gene-editing approaches, and therapies for serious diseases.

What you will do

• Provide quality oversight for the creation, review, approval, revision, periodic review, and retirement of Development controlled documents in Veeva Quality.
• Guide Development stakeholders on document requirements, workflows, templates, deviations, CAPAs, effectiveness checks, and QMS activities.
• Monitor QMS metrics and trends, identify systemic risks, and prepare materials for biannual quality management review meetings.
• Conduct clinical study report, trial master file, and other GCP-related audits, including review of responses and corrective actions.
• Support the planning, preparation, conduct, and follow-up of global Health Authority inspections.
• Maintain regulatory intelligence and use approved digital and AI-enabled tools with appropriate human review.

Requirements

• Bachelor’s degree and at least 5 years of GCP quality assurance experience, or an equivalent combination of education and experience.
• Strong knowledge of clinical development, ICH Guidelines, global GCP requirements, and quality management principles.
• Experience with GCP, document, and TMF audits; controlled document lifecycle activities; and document quality reviews.
• Experience with electronic QMS platforms; Veeva Quality experience is preferred.
• Strong communication, collaboration, organizational, time management, and problem-solving skills.
• Ability to manage multiple projects, meet accelerated timelines, work across geographies, and travel on short notice when required.

Nice to have

• Healthcare or scientific education.
• Experience writing and reviewing clinical research SOPs.
• Knowledge of additional GxP areas such as GVP.

Culture & Benefits

• Remote work environment with opportunities to collaborate across geographies.
• Benefits package provided.
• Work focused on medicines and scientific solutions for patients with serious diseases.
• Support for innovation, scientific excellence, and professional development.