Director of Clinical Quality & Regulatory Oversight

ABOUT THE ROLE The Director of Clinical Quality & Regulatory Oversight owns the systems, processes, and manages the people that keep our front line compliant and error-free. You will continue to build and lead high-performing Quality Assurance & Regulatory teams, set clear metrics for performance, and create scalable frameworks (QMS & CTMS updates, SOPs, dashboards, and training programs) that prevent issues before they occur. This role spans proactive quality management, regulatory submissions/maintenance, audit readiness, and continuous improvement—ensuring our studies meet ICH-GCP, FDA, and IRB requirements while moving fast and delivering impeccable data. You are comfortable rolling up your sleeves to design a quality assurance framework, workflow, coaching both your staff and clinical research coordinators on KPIs, and presenting an audit plan to executives. Success will be measured by measurable reductions in errors, QMS framework, all SOPs version-controlled and established for all departments, >95% staff trained on time, 100% on-time IRB submissions across active studies, zero critical audit findings; all minor/major findings closed within target timelines, documented CAPA program with measurable closure rates and demonstrated prevention of repeat issues, and a culture of accountability and continuous improvement across clinical operations. Key Responsibilities In consultation with Executive Director of Clinical Operations and Head of HR, define, track, and manage to team and individual-level KPIs (e.g., % on-time submissions, audit findings per site, training compliance) Run regular metric reviews and performance calibrations; implement corrective actions when targets are missed Foster a culture of accountability, transparency, and continuous improvement. Own the Quality Management System (Dot Compliance), including SOPs, work instructions, templates, and training matrices Implement technology-enabled workflows (e.g., eTMF/EDMS, CTMS, QMS tools) to standardize and error-proof processes Lead root-cause analyses and CAPA programs that permanently fix systemic issues Create dashboards and feedback loops that surface risk early and minimize downstream fixes Develop and execute risk-based monitoring and internal data quality review plans (e.g., 10% DQR or protocol-specific targets) Ensure adherence to ICH-GCP, FDA regulations, study protocols, and internal SOPs across all sites. Verify accuracy of clinical data; manage discrepancies and drive timely resolution Maintain an annual audit plan for all sites and functions; ensure perpetual “audit-ready” status Oversee full lifecycle regulatory activities for sites/PIs: start-up packages, amendments, continuing reviews, safety reports, and close-out Own IRB communications and ensure on-time, high-quality submissions of protocols, ICFs, and amendments Maintain and QC Investigator Site Files/Regulatory Binders and essential documents. Stay current on FDA, ICH, and IRB requirements; translate regulatory changes into updated processes and training Direct and/or host sponsor, CRO, and FDA audits; serve as internal escalation point for quality matters Coordinate and document internal audits of study teams, systems, and documents; drive remediation plans to closure Ensure 100% compliance and timely retraining after SOP/process changes. Deliver or coordinate targeted trainings (micro-trainings, refreshers) based on trend data and audit findings Lead change-management efforts to embed new processes and tools effectively Act as the primary conduit between study sites, clinical operations, sponsors, and regulatory bodies on quality/reg matters Provide timely, concise reporting to leadership on quality KPIs, risks, and mitigation plans Partner with Ops, Data, Product/Tech to design scalable, compliant workflows Minimum Qualifications Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality Management, or related field or ≥4 years equivalent experience 8+ years in clinical research quality, regulatory, and/or clinical operations (pharma, biotech, CRO, or tech-enabled research), preferably quality assurance and regulatory . 5+ years of people leadership with proven success managing to metrics and improving team performance 5+ years working directly with GCP, FDA, and ICH guidelines; strong IRB submission experience 5+ years hands-on experience with eTMF/EDMS, CTMS, and/or QMS platforms 3+ years direct IRB submission/oversight experience. Preferred Qualifications Professional certifications (e.g., SOCRA, ACRP, RAC). Located in Ann Arbor, Baltimore, Denver, DC, or Nashville

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