Oruka Therapeutics

Director, Clinical Quality Assurance

Waltham, Massachusetts, United States · Director

Sponsorship not specified$10k-$15kDetected 104 days ago

GCPClinical TrialsFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationGxPRegulatory Affairs

About the role

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.
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.

Responsibilities

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.
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.
Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed.
Partner with Clinical Operations and cross-functional teams to support quality risk assessments, critical data/process identification, quality tolerance considerations where appropriate, and evaluation of key risk indicators and centralized quality signals.
Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development.
Serve as the primary Clinical QA lead for FDA BIMO inspection readiness and support for other global regulatory inspections involving clinical trial activities.

Requirements

10+ years of experience in Clinical QA/GCP Quality within biotechnology, pharmaceuticals, or a CRO environment.
Strong knowledge of GCP and applicable global clinical regulatory requirements.
Experience supporting quality oversight for Phase 1-3 clinical trials.
Demonstrated experience with GCP audits, including investigator site and/or vendor audits.
Experience supporting clinical deviations, investigations, CAPAs, and related quality system activities.
Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO inspections.
Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors.
Excellent judgment, communication, and collaboration skills, with the ability to influence across functions in a fast-paced environment.

Nice to have

Experience as an early Clinical QA hire in a growing biotech company.
Experience supporting biologics development programs.
Familiarity with eQMS tools and clinical systems relevant to quality oversight.
Experience with risk-based quality management and quality metrics.
Waltham, MA candidates preferred
Join us in shaping the future of our company and making a real impact every day.
Waltham, MA area candidates preferred.
advanced degree preferred.

Compensation

An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
The anticipated salary range for candidates is $213,000 - $240,000.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.
Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
Waltham, MA candidates preferred
We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Benefits

Competitive salary and benefits package.
Provide quality support and oversight related to Trial Master File (TMF) health, inspection-ready documentation practices, and completeness of essential records.

Company info

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
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.
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.

Visa & Work Authorization

Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors

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This listing is sourced directly from Oruka Therapeutics's careers page and normalized into a canonical job model.