Executive Director, Clinical Quality Assurance

About Jade Biosciences


Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade's pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.


Role Overview


The Executive Director, Clinical Quality Assurance (CQA) will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GPvP) and Good Laboratory Practices (GLP) activities to ensure quality assurance and compliance of Jade sponsored clinical trials with applicable regulations, ICH guidelines, OECD Principles of GLP, Jade procedures and policies, and current industry standards and practices.

The Executive Director, Clinical Quality Assurance will perform day-to-day clinical quality operations and compliance activities to support the success of our clinical programs in addition to being a strategic partner to Clinical Development and Operations. This role will maintain and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory standards. The ideal candidate brings hands-on expertise in GCP, GPvP and GLP QA operations, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Key Responsibilities

• Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents.
• Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management.
• Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issues.
• Represent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetings.
• Oversee ongoing clinical programs to ensure they are risk-based, fit-for-purpose and in compliance with applicable regulations and guidelines across all phases of development.
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings.
• Develop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies.
• Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures.
• Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory compliance.
• Identify and assess compliance risk and develop and implement risk mitigation measures.Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process.
• Contribute to building a strong quality culture within the organization.
• Ensure the timely and effective follow up of all identified or assigned quality issues.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions.
• Champion continuous improvement and simplification across clinical quality systems.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies.
• Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
• Apply risk-based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy.
• Understand when to escalate, when to intervene, and when to let teams move forward without over engineering processes.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Qualifications

• Bachelors + 17 or Masters + 15 or PhD + 10 years of related experience Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies.
• Successful track record of translation and implementation of clinical requirements into operational execution.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities.
• Knowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industry.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
• Strong organizational skills and the ability to participate effectively cross-functionally.
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Proficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).

Position Location


This is a remote role; periodic travel to team and company events is required.


The anticipated salary range for candidates for this role is$265,000 - $300,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.


As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.

Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.