Director/ Senior Director, GVP Quality Assurance
SolenoRedwood City, California, United States
Posted February 10, 2026
235000 - 280000 USD
Full Time
About the Company
Soleno Therapeutics is a biopharmaceutical company dedicated to developing innovative therapies for rare diseases, with a particular focus on Prader-Willi syndrome. In March 2025, the company secured FDA approval for its first and only treatment targeting hyperphagia in PWS, marking a significant milestone in addressing a critical unmet medical need. Leveraging a rigorous scientific approach alongside strong advocacy and community engagement, Soleno blends cutting-edge research with patient-centric values to deliver impactful solutions. The organization fosters a collaborative culture that empowers scientists, clinicians, and patients to work together toward transformative health outcomes.
Job Description
The Director/Senior Director, GVP Quality Assurance, is responsible for supporting the development, coordination and implementation of Global Pharmacovigilance regulations related to quality assurance activities. This individual will serve as the primary QA inspection lead for pharmacovigilance activities, ensuring that Soleno maintains continuous inspection readiness across PV systems, vendors, and processes/documents at all times.
Requirements
- Ensure compliance with global pharmacovigilance regulations, including FDA postmarketing safety requirements, EMA GVP modules, and ICH guidelines
- Implement and maintain the risk-based internal and external (vendor) PV audit program
- Lead PV inspection readiness activities, including gap analyses, mock inspections, and other inspection preparations as applicable
- Oversee deviations impacting on PV
- Perform induction and ongoing PV training of Soleno’s employees
- Liaise with other QA functions to collate, review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations
- Respond to general PV-QA queries and provide advice and guidance to PV Operations, QA and other functional groups in relation to PV topics
- Monitor, analyze and communicate PV regulation, guidance changes
- Coordinate with GMP QA, GCP QA and Quality Systems QA colleagues ensuring harmonized quality approaches
- Attend company, departmental and cross-functional meetings as required
- Report to supervisor on project progress, issues, and problem solving
- Perform other relevant duties as assigned
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
