REQUIREMENTS: For the Assistant Director role, a bachelor's degree with a minimum of 8 years, a master's degree with a minimum of 6 years, a PhD with a minimum of 3 years: for the Associate Director a bachelor's degree with a minimum of 12 years, a master's degree with a minimum of 8 years, a PhD with a minimum of 5 years of GVP quality assurance or relevant clinical trial safety experience within the pharmaceutical and biotechnology industry and/or service provider work experience is required; a healthcare/scientific-related discipline is highly desirable. This role partners closely with Patient Safety and Pharmacovigilance, Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, GMP QA, business partners, and service providers to support audit execution, inspection readiness, PV quality systems support, service provider oversight, metrics, and continuous improvement activities, in alignment with Ionis PV QA expectations.