Director/ Senior Director, GVP Quality Assurance

Director/ Senior Director, GVP Quality Assurance 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 serves as the primary QA inspection lead for pharmacovigilance activities, ensuring continuous inspection readiness across PV systems, vendors, and processes/documents at all times. The role ensures Good Pharmacovigilance Practice (GVP) within Soleno throughout all phases of the product development life cycle, including post‑marketing stages globally. Responsibilities 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, including risk strategy, tactical and operational audit planning: Ensure PV audits are scheduled, conducted and reported as planned. Ensure PV audit CAPAs are established, agreed and tracked to closure. Ensure PV audit metrics are prepared, analyzed and improvements instituted. Inspection readiness: Lead PV inspection readiness activities, including gap analyses, mock inspections, and other inspection preparations as applicable. Serve as the QA inspection lead during any FDA, EMA, or other global health authority PV inspections. Coordinate inspection logistics including war‑room management, document requests, and responses to inspectors. Ensure timely and high‑quality resolution of any observations obtained during inspections. Oversee deviations impacting PV: Identify and monitor deviations impacting PV. Ensure CAPAs are established. Verify effectiveness of the CAPAs. Support periodic and ad‑hoc review of PV department policies, procedures, and work instructions. Support review of quality systems procedures from a PV QA compliance perspective. Perform induction and ongoing PV training for Soleno’s employees. Liaise with other QA functions to review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations. Provide EU QPPV with necessary QA data allowing oversight of the PV quality system. Oversight of PV compliance metrics and perform trending where required. Manage the product complaint process, oversight of product complaint compliance metrics and perform trending where required. 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 and guidance changes. Coordinate with GMP QA, GCP QA and Quality Systems QA colleagues to ensure 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. Qualifications A degree in a scientific or technical discipline with a graduate degree preferred. 8‑10 years GVP experience in biotech/pharmaceutical industry, including direct, hands‑on experience supporting and/or leading regulatory inspections. Experience interacting directly with FDA, EMA and other global health authorities in the context of PV inspections or other regulatory inquiries. Knowledge of quality standards and regulatory guidelines relating to pharmaceutical and/or biotech products and a strong working knowledge of global GVP regulations and guidance. Demonstrated skills and experience in the conduct of quality activities as described above. Experience with internal Quality Systems auditing. A highly motivated, organized and methodical individual with strong project management, analytical, problem‑solving and interpersonal skills. Good prioritization capability and comfort adapting to changing priorities. Excellent interpersonal skills with an ability to communicate quality concepts effectively. Excellent collaboration skills to optimize relationships with internal and external partners. Comfortable working in an environment where QMS will expand and grow in support of company growth. Ability to travel is required. Anticipated travel: 30%. Salary Range $235,000 - $280,000 (Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.) #J-18808-Ljbffr SupportFinity™