Title: Director - Senior Director, Quality

Location: Remote (United States)

Department: Scientific R&D;

Job Description

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 transparent 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, op

📌 Director - Senior Director, Quality job at Character Biosciences in Brisbane, QLD, Australia, Jersey City, NJ or US National
🏢 Character Biosciences
📍 Brisbane