[Remote] Executive Director, Clinical Quality Assurance

Note: The job is a remote job and is open to candidates in USA. Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The Executive Director, Clinical Quality Assurance will oversee all aspects of Quality Assurance related to clinical trials, ensuring compliance with regulations and guiding cross-functional teams in maintaining high standards.

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

Skills

• 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)

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