Director​/Senior Director, Quality

Character Bio is a clinical-stage biotechnology company working to preserve vision in people with serious, progressive eye diseases. Founded in 2018, the company has built the most advanced disease intelligence system for drug development in ophthalmology, starting with dry Age-related Macular Degeneration (AMD). This system fully integrates genomics with longitudinal clinical and imaging data to characterize the pathogenic drivers of disease progression.

Leveraging the insights from its disease intelligence system, Character is advancing two innovative, homegrown programs in Phase 1 studies while continuing to expand its discovery-stage pipeline. The company’s interdisciplinary team spans observational clinical research, data science and AI, drug discovery, clinical development, manufacturing, and commercialization. Character is well capitalized, having raised more than $110 million in Series B financing from leading healthcare and technology investors, and maintains a multi-target drug discovery collaboration with Bausch + Lomb.

Role :
Director / Senior Director, Quality

Reports to: CSO

Department: Scientific R&D

Level: 9 or 10

Location :
Brisbane, CA;
Jersey City, NJ; or Remote

We're looking for a hands-on, execution-focused quality leader to build and own Character's GxP quality system as the company moves into Phase 2. You'll own clinical quality (GCP) and CMC quality (GMP) end to end — procedure lifecycle, quality management system (Qualio), vendor qualification and oversight, training, audits and inspection readiness — and right-size the system so that a fifty-person company can actually run it.

This role is hybrid/remote role based out of our Jersey City, NJ or Brisbane, CA offices and reports to the CSO (Brisbane).

• Own the clinical quality management system end to end: document control, procedure lifecycle, training, deviations, CAPA, quality issue escalation and periodic review.
• Maintain the procedure set at a size and shape Character can comply with. Author, revise, consolidate and retire SOPs through controlled document lifecycle, with documented rationale, process-owner agreement and quality approval.
• Serve as Qualio administrator and process owner: configuration, workflows, document control, training curricula and assignment, periodic review cycles, change control, and the reporting that demonstrates an actively managed system.
• Establish and implement a fit-for-purpose, risk-based GxP vendor qualification and oversight framework — including tiered qualification criteria, initial and periodic re-qualification assessments, and ongoing performance monitoring. Own qualification records and quality agreements end to end, ensuring each clearly defines quality roles, responsibilities, and escalation pathways between Character and the vendor.
• Apply risk-based quality management: identify critical-to-quality factors, document quality risk assessments per protocol, and direct oversight to where risk to patients and data integrity actually sits.
• Own GCP and role-based training across the company: curricula, assignment, completion and competency tracking.
• Manage sponsor audits and regulatory inspections and drive responses and CAPA to closure.
• Oversee vendor quality event reporting and trending across the vendor network: define reporting requirements and timelines in quality agreements, track and trend events by vendor and category, roll up global metrics for leadership visibility, and ensure vendor-originated events feed into the CAPA system with clear ownership and closure tracking.
• Run a risk-scoped audit program covering vendors, investigator sites and internal processes.
• Serve as the quality interface with functional owners (Clinical…