Assistant/Associate Director, Pharmacovigilance Quality Assurance

Location: Remote, US-based; at least 10–15% travel required.

Salary: $121,205–$196,548 annually. Assistant Director range: $121,205–$162,726; Associate Director range: $138,908–$196,548.

Company

Ionis is a biotechnology company developing RNA-targeted medicines and advancing gene-editing approaches for serious diseases.

What you will do

• Support and maintain a risk-based GVP quality program covering clinical trial and post-marketing safety processes.
• Plan, conduct, and support end-to-end audits of service providers, business partners, affiliates, and internal pharmacovigilance processes.
• Prepare audit reports, evaluate responses and CAPA plans, and track corrective actions through completion.
• Support regulatory inspection readiness, health-authority inspections, partner audits, and assessment of related findings and risks.
• Provide quality oversight for PV service providers, quality agreements, deviations, investigations, change controls, and PASS-related activities.
• Develop PV quality metrics and dashboards, provide training, and mentor or support Development QA personnel.

Requirements

• Assistant Director: bachelor’s degree plus 8 years, master’s plus 6 years, or PhD plus 3 years of relevant experience. Associate Director: bachelor’s plus 12 years, master’s plus 8 years, or PhD plus 5 years.
• Experience in GVP quality assurance or clinical trial safety within the pharmaceutical, biotechnology, or service-provider industry.
• Strong GVP auditing experience, including internal-process, business-partner, and service-provider audits.
• Knowledge of international GVP regulations, FDA and EMA requirements, GCP regulations, health-authority guidance, and ICH guidelines.
• Experience with regulatory inspections, inspection readiness, SOPs, controlled documents, CAPAs, deviations, and change controls.
• Ability to work remotely from the United States and travel at least 10–15%, including on short notice when needed.

Nice to have

• Healthcare or scientific-related degree.
• GCP auditing experience.
• Knowledge of computer system validation and data integrity concepts for GVP/GCP systems.

Culture & Benefits

• Remote, hybrid, and onsite work environments are supported.
• Cross-functional collaboration with Patient Safety, Pharmacovigilance, Clinical Operations, Regulatory Affairs, Medical Affairs, and business partners.
• Benefits package provided.
• Approved AI-enabled and digital tools may be used with required human review and regulatory oversight.