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Salary: USD 200,000 - 270,000 / annual
Character Biosciences is a clinical-stage biotechnology company focused on preserving vision in people with serious, progressive eye diseases. Founded in 2018, the company has built an advanced disease intelligence system for drug development in ophthalmology, integrating genomics with longitudinal clinical and imaging data. The company is well-capitalized with over $110 million in Series B funding and maintains a multi-target drug discovery collaboration with Bausch + Lomb.
This is a hands-on, execution-focused quality leadership role responsible for building and owning Character's GxP quality system as the company advances into Phase 2 clinical development. The Director/Senior Director will own both clinical quality (GCP) and CMC quality (GMP) end-to-end, including procedure lifecycle management, quality management system administration (Qualio), vendor qualification and oversight, training, audits, and inspection readiness. The role requires right-sizing the quality system so that a fifty-person company can effectively operate and maintain compliance.
Key responsibilities include: establishing and maintaining the clinical quality management system (document control, procedure lifecycle, training, deviations, CAPA, quality issue escalation); managing the Qualio QMS platform as administrator and process owner; implementing a risk-based GxP vendor qualification and oversight framework with tiered criteria and ongoing performance monitoring; owning GCP and role-based training across the company; managing sponsor audits and regulatory inspections; overseeing vendor quality event reporting and trending; running a risk-scoped audit program covering vendors, investigator sites, and internal processes; serving as the quality interface with functional owners and GCP subject matter expert; owning the GMP quality system including document control, deviations, change control, and CAPA; qualifying and auditing contract manufacturers and CDMOs; managing GLP oversight of nonclinical programs; and proactively surfacing quality risks and trends to leadership.
The role reports to the Chief Scientific Officer and is based out of either the Jersey City, NJ or Brisbane, CA offices with hybrid/remote flexibility.
Requirements: The posting does not explicitly state years of experience, specific certifications, or educational requirements in the provided excerpt. However, the role clearly requires deep expertise in GxP quality systems (GCP and GMP), clinical trial quality management, CMC/manufacturing quality, vendor management, regulatory compliance, and QMS platforms. Candidates should have demonstrated experience building and scaling quality systems in biotech/pharma environments, particularly in clinical development and manufacturing contexts.
