Assistant/Associate Director, Pharmacovigilance Quality Assurance
$121,205–$196,548 year
On-siteCarlsbad, California, United States
Job Summary
Execute risk-based GVP audits of service providers, business partners, and internal PV processes, including preparation, execution, reporting, and CAPA follow-up. Lead inspection readiness activities, assess regulatory authority inspection reports, and provide QA guidance and training to internal stakeholders. Support Patient Safety, Clinical Development, and Regulatory Affairs with quality oversight for deviations, CAPAs, change controls, and service provider governance. Maintain PV QA metrics, SOPs, and documentation to ensure sustained compliance and continuous improvement. Work remotely with 10-15% travel; salary ranges from $121,205 to $196,548. Join Ionis to drive innovation in RNA therapies and gene editing for patients with unmet needs.
Required Qualifications
- bachelor's degree
- minimum of 8 years, a master's degree with a minimum of 6 years, a PhD with a minimum of 3 years
- GVP quality assurance or relevant clinical trial safety experience
- pharmaceutical and biotechnology industry and/or service provider work experience
- healthcare/scientific-related discipline
- Strong GVP auditing and clinical safety experience
- internal process, business partner, and service provider audits
- Working knowledge of international GVP regulations
- FDA and EMA pharmacovigilance and clinical trial safety requirements
- GCP regulations
- applicable health authority guidance
- ICH guidelines
- Experience supporting or participating in global regulatory inspections
- partner audits and inspection-readiness activities
- Good understanding of the clinical development process
- risk-based quality systems approaches
- clinical PV and post-market PV activities
- Experience writing, reviewing, and revising SOPs
- other controlled documents supporting PV activities
- Strong interpersonal, verbal, and written communication skills
- ability to work effectively across functions
- influence without direct authority
- Strong organizational and time management skills
- ability to manage multiple priorities in a dynamic environment
- Ability to travel
- at least 10-15% travel
Desired Qualifications
- GCP auditing experience
- Experience with PV-related service provider oversight
- quality agreements
- CAPAs, deviations, and change controls
- Knowledge of computer system validation
- data integrity concepts relevant to GVP/GCP systems
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