Director, Clinical Quality Assurance

About Us: 

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.  Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.  

Job Title: Director, Clinical Quality Assurance

Location: Remote; Waltham, MA area candidates preferred. 

Role Overview:

The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

This role will partner closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure that clinical studies are conducted in accordance with GCP, applicable global regulations, internal procedures, and protocol requirements. The Director, Clinical QA will provide proactive quality input across the clinical trial lifecycle, support continuous improvement, and help build a quality-focused culture as the organization advances its pipeline.

 Key Responsibilities:

• Clinical Quality Oversight: Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP, applicable regulatory requirements, and internal procedures. Serve as the primary quality business partner to Clinical Operations and other development functions to identify, assess, and mitigate quality and compliance risks across the clinical trial lifecycle. Review key study-level documents for quality and compliance, including protocols, informed consent forms, investigator brochures, monitoring plans, vendor oversight plans, data review plans, study reports, and essential trial documentation. Support development and implementation of phase-appropriate clinical quality procedures and processes.
• Quality Systems Support for Clinical Development: Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development. Ensure appropriate escalation, documentation, trending, and management visibility for significant quality issues. Partner cross-functionally to identify recurring themes, systemic risks, and opportunities for process improvement. Establish and maintain clinical quality metrics and dashboards to support management review and continuous improvement.
• Vendor and CRO Quality Oversight: Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs. Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed. Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.
• Audit Program Execution: Develop and execute a phase-appropriate GCP audit strategy and annual audit program based on risk, program priorities, and business needs. Conduct and/or manage investigator site, vendor, study-specific, and for-cause audits as needed. Author audit plans, reports, observations, and follow-up actions, and ensure timely resolution of audit findings through appropriate CAPA management and verification of effectiveness. Travel to clinical sites, vendors, and investigator meetings as needed.
• Inspection Readiness and Health Authority