Director / Senior Director, Quality

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).

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.

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.

• 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.

Applicants must be authorized to work in the United States.