Base: $235,000 - $280,000; bonus/equity: not speci...
On-site
Global pharmacovigilance regulations compliance
Pharmacovigilance audit program management
Inspection readiness and gap analysis
Soleno Therapeutics is a biopharmaceutical company focused on developing novel therapeutics for rare diseases with a strong commitment to collaboration, integrity, and respect
Job Summary
Soleno Therapeutics is a biopharmaceutical company focused on developing novel therapeutics for rare diseases with a strong commitment to collaboration, integrity, and respect.
The Director/Senior Director, GVP Quality Assurance, will lead global pharmacovigilance quality assurance efforts, including audit programs, inspection readiness, and quality system oversight throughout the product lifecycle.
This role requires interaction with global health authorities, management of deviations and CAPAs, and coordination across multiple QA functions to ensure continuous compliance and inspection readiness.
Matching Summary
Soleno Therapeutics is a biopharmaceutical company focused on developing novel therapeutics for rare diseases with a strong commitment to collaboration, integrity, and respect.
Salary
Base: $235,000 - $280,000; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Global pharmacovigilance regulations compliance
Pharmacovigilance audit program management
Inspection readiness and gap analysis
Pharmacovigilance quality system oversight
Risk-based audit planning and execution
Vendor pharmacovigilance oversight
Pharmacovigilance System Master File support
Nice-to-have
Experience in virtual pharmaceutical environment
Strong project management skills
Excellent interpersonal and communication skills
Collaboration with internal and external partners
Adaptability to growing quality management systems
Key Requirements
8-10 years GVP experience in Biotech/Pharmaceutical Industry
Direct experience supporting or leading regulatory inspections
Knowledge of FDA, EMA, and ICH pharmacovigilance regulations
Experience conducting internal quality systems auditing