A bachelor's degree in a life science or related field and at least ten years of GxP quality assurance experience in biotechnology or biopharmaceuticals are required. For the Senior Director level, at least three years at Director level or equivalent accountability is required.
Hands-on clinical quality experience for interventional trials, including vendor qualification, deviation and CAPA management, and inspection, is required.
Hands-on GMP quality experience is required, including personal review and disposition of executed batch records, temperature excursion assessments, CDMO/CRO audits, and person-in-plant work. Oversight of someone else performing this work does not meet the requirement.
Experience owning an electronic quality management system as administrator or process owner is required, including configuration, document control, training curricula and assignment, periodic review, and change control. Qualio is preferred; MasterControl, Veeva, ZenQMS, or comparable systems are acceptable if the candidate demonstrates deep experience rather than basic use.
Demonstrated experience retiring or consolidating procedures, and defending those decisions to an auditor, is required.
A working command of ICH E6(R3), ICH Q9 and Q10, and 21 CFR Parts 11, 210, 211, and 312 is required.
Experience serving as the quality function at a company with roughly fewer than one hundred people and no quality department beneath the role is required.
Willingness to be the accountable quality signatory and uphold quality decisions with executives, vendors, and investigators is required.
Responsibilities
Own the clinical quality management system end to end, including document control, procedure lifecycle, training, deviations, CAPA, quality issue escalation, and periodic review.
Maintain a procedure set that the company can comply with; author, revise, consolidate, and retire SOPs through a controlled document lifecycle with documented rationale, process-owner agreement, and quality approval.
Serve as Qualio administrator and process owner, managing configuration, workflows, document control, training curricula and assignments, periodic review cycles, change control, and reporting that demonstrates active system management.
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, ensuring they define quality roles, responsibilities, and escalation pathways between the company and vendors.
Apply risk-based quality management by identifying critical-to-quality factors, documenting quality risk assessments for each protocol, and directing oversight to risks to patients and data integrity.
Own GCP and role-based training across the company, including curricula, assignments, 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, report global metrics to leadership, 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, including Clinical Operations, Regulatory, and CMC/Biometrics, and as the GCP subject matter expert on protocol design, study conduct, and regulatory expectations. Surface quality risks and trends to functional and senior leadership, and partner cross-functionally to integrate quality considerations into study planning and decisions.
Own the GMP quality system within the same Qualio instance, ensuring document control, deviations, change control, CAPA, and training follow common governance.
Qualify and audit contract manufacturers, substance CDMOs, fill-finish operations, testing laboratories, labelling and packaging suppliers, and the depot and distribution network as needed by project.
Provide quality oversight of manufacturing campaigns, including person-in-plant presence for critical operations, batch record review at the site, and real-time deviation decisions when needed.
Maintain good distribution practice for cold-chain clinical supply, including shipping qualification, temperature monitoring, excursion disposition, and depot oversight.
Own product complaint, investigation, and recall procedures for clinical supply, and conduct periodic product quality review as applicable.
Desired Qualifications
Sponsor-side experience with global trials.
Experience with Qualio specifically as an administrator rather than a user.
Experience hosting or supporting a sponsor inspection, such as FDA BIMO, EMA, or MHRA, and managing its findings.
Computerized system validation and Part 11 compliance experience for clinical systems, including EDC, IRT, eTMF, and imaging or reading-center platforms.
Experience taking a company from Phase 2 into Phase 3 or registrational work.
GLP oversight of nonclinical programs.
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
The Opportunity
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).
Responsibilities
Clinical Quality (GCP)
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 Operations, Regulatory, CMC/Biometrics, etc.) and the go-to GCP subject matter expert on protocol design, study conduct, and regulatory expectations. Proactively surface quality risks and trends to functional and senior leadership, and partner cross-functionally to embed quality considerations into study planning and decisions.
CMC Quality (GMP)
Own the GMP quality system and keep it within the same Qualio instance, ensuring document control, deviations, change control, CAPA and training under common governance
Qualify and audit contract manufacturers, substance CDMOs, fill-finish operations, testing laboratories, labelling and packaging suppliers, and the depot and distribution network, per project needs
Provide quality oversight of manufacturing campaigns, including person-in-plant presence for critical operations, batch record review at site, and real-time deviation decisions, if needed
Maintain good distribution practice for cold-chain clinical supply: shipping qualification, temperature monitoring, excursion disposition and depot oversight
Own product complaint, investigation and recall procedures for clinical supply, and periodic product quality review as applicable.
About You
You bring deep GxP judgment and the willingness to be hands-on. You move fluidly between designing a quality system and doing the work inside it — reviewing the executed batch record, configuring document control and training in a QMS, writing the vendor oversight plan, sitting on the CRO governance call. You know the regulations well enough to apply them proportionately, and you can tell the difference between a procedure that reduces real risk to patients and data and one that a larger company carries out of habit. You are as willing to retire a procedure as to write one, and you can defend either decision to an inspector. Like us, you value integrity, individual accountability, team camaraderie, open communication, and a commitment to doing regulated work well because patients depend on it.
Required Qualifications
Bachelor’s degree in a life science or related field, and at least ten years in GxP quality assurance in biotechnology or biopharmaceuticals. For the Sr Director level, three or more years at Director level or with equivalent accountability.
Hands-on clinical quality for interventional trials: vendor qualification, deviation and CAPA management, and inspection.
Hands-on GMP quality: personal review and disposition of executed batch records, temperature excursion assessments, CDMO/CRO audit, and PIP. Oversight of someone else performing this work does not meet the bar.
Ownership of an electronic quality management system as administrator or process owner — configuration, document control, training curricula and assignment, periodic review and change control. Qualio preferred; MasterControl, Veeva, ZenQMS or comparable systems are acceptable where the candidate can demonstrate depth rather than use.
Demonstrated experience retiring or consolidating procedures, not only authoring them, and defending those decisions to an auditor.
Working command of ICH E6(R3), ICH Q9 and Q10, and 21 CFR Parts 11, 210, 211 and 312.
Experience as the quality function at a company of under roughly one hundred people, with no quality department beneath them.
Willingness to be the accountable quality signature and to hold that line with executives, vendors and investigators.
Preferred qualifications
Sponsor-side experience with global trials
Qualio specifically, as administrator rather than user.
Having hosted or supported a sponsor inspection — FDA BIMO, EMA or MHRA — and lived with the findings.
Computerized system validation and Part 11 compliance for clinical systems: EDC, IRT, eTMF, and imaging or reading-center platforms.
Having taken a company from Phase 2 into Phase 3 or registrational work.
GLP oversight of nonclinical programs.
Open, positive, and collaborative
Compensation & Benefits
At the Director level, the annual pay range for this full-time position is $200,000-$230,000. At the Sr. Director level, the annual pay range is $240,000-$270,000. Actual compensation packages are based on a wide array of factors unique to each candidate including but not limited to skill set, years and depth of experience, certifications and work location.
EEO Statement
Character Biosciences is an equal opportunity employer and is committed to building a diverse and inclusive workforce. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.
Work Authorization
Applicants must be authorized to work in the United States.