[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.ResponsibilitiesProvide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documentsProvide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue managementAct as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issuesRepresent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetingsOversee ongoing clinical programs to ensure they are risk‑based, fit‑for‑purpose and in compliance with applicable regulations and guidelines across all phases of developmentReview and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filingsDevelop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studiesEstablish and maintain GCP/GPvP/GLP QA programs, policies and proceduresWork collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory complianceIdentify and assess compliance risk and develop and implement risk mitigation measuresLead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA processContribute to building a strong quality culture within the organizationEnsure the timely and effective follow up of all identified or assigned quality issuesDirect and/or deliver yearly training for internal staff as neededWork closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactionsChampion continuous improvement and simplification across clinical quality systemsPrepare KPIs, metrics and analysis and present status updates as neededProvide leadership in inspection preparedness to clinical sites and service providers for regulatory government agenciesStay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA functionApply risk‑based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracyUnderstand when to escalate, when to intervene, and when to let teams move forward without over engineering processesProvide clear, concise guidance that helps teams stay focused, aligned, and inspection readySkillsBachelors + 17 or Masters + 15 or PhD + 10 years of related experienceExtensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studiesSuccessful track record of translation and implementation of clinical requirements into operational executionExtensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practicesA successful track record of working with service providers and CROsAbility to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerationsHighly skilled in the ability to work with ambiguity and complexityAbility to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activitiesKnowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industryExpertise 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 agenciesStrong organizational skills and the ability to participate effectively cross-functionallyA self-starter and a team player who thrives in a fast-paced dynamic team environmentAbility to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence othersPrior management experience is requiredPrevious experience in successfully leading assigned activities within cross-functional teamsProficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint)Company OverviewJade Biosciences is developing transformative therapies to redefine the standard of care for inflammation and immunology indications. It was founded in 2024, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 11-50 employees. Its website is https://jadebiosciences.com.