Director – Quality

Character Biosciences

. Build and own Character’s GxP quality system as the company moves into Phase 2 .

Posted 10/16/2026full-timeUnited StatesSenior💰 $200,000 - $270,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Build and own Character’s GxP quality system as the company moves into Phase 2
Own clinical quality (GCP) and CMC quality (GMP) end to end
Manage procedure lifecycle, quality management system, vendor qualification and oversight, training, audits and inspection readiness
Own the clinical quality management system, including document control, procedures, training, deviations, CAPA, quality issue escalation and periodic review
Author, revise, consolidate and retire SOPs through controlled document lifecycle
Serve as Qualio administrator and process owner
Establish and implement a risk-based GxP vendor qualification and oversight framework
Own qualification records and quality agreements
Apply risk-based quality management and direct oversight to critical patient and data integrity risks
Own GCP and role-based training across the company
Manage sponsor audits and regulatory inspections and drive responses and CAPA to closure
Oversee vendor quality event reporting and trending
Run a risk-scoped audit program covering vendors, investigator sites and internal processes
Serve as quality interface with Clinical Operations, Regulatory, CMC/Biometrics and other functional owners
Provide GCP subject matter expertise on protocol design, study conduct and regulatory expectations
Surface quality risks and trends to leadership and embed quality considerations into study planning
Own the GMP quality system under common Qualio governance
Qualify and audit contract manufacturers, substance CDMOs, fill-finish operations, testing laboratories, labelling and packaging suppliers, and depot/distribution networks
Provide quality oversight of manufacturing campaigns, including person-in-plant presence, batch record review and real-time deviation decisions
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 periodic product quality review

Requirements

What you’ll need

Bachelor’s degree in a life science or related field
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, including vendor qualification, deviation and CAPA management, and inspection
Hands-on GMP quality, including personal review and disposition of executed batch records, temperature excursion assessments, CDMO/CRO audit, and person-in-plant (PIP)
Ownership of an electronic quality management system as administrator or process owner, including configuration, document control, training curricula and assignment, periodic review and change control
Qualio preferred; MasterControl, Veeva, ZenQMS or comparable systems acceptable with demonstrated depth
Demonstrated experience retiring or consolidating procedures 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 hold that line with executives, vendors and investigators
Sponsor-side experience with global trials preferred
Qualio specifically as administrator rather than user preferred
Experience hosting or supporting a sponsor inspection (FDA BIMO, EMA or MHRA) preferred
Computerized system validation and Part 11 compliance for clinical systems: EDC, IRT, eTMF, and imaging or reading-center platforms preferred
Experience taking a company from Phase 2 into Phase 3 or registrational work preferred
GLP oversight of nonclinical programs preferred
Authorized to work in the United States
Open, positive, and collaborative