Director of Clinical Quality & Regulatory Oversight

Summary

Join our team as Director of Clinical Quality & Regulatory Oversight and lead high-performing teams in ensuring compliance and error-free operations. You will build and implement quality management systems, regulatory processes, and training programs. Responsibilities include defining and tracking KPIs, conducting regular metric reviews, fostering a culture of continuous improvement, and overseeing regulatory activities. You will also lead root-cause analyses, manage discrepancies, maintain audit readiness, and ensure compliance with ICH-GCP, FDA, and IRB requirements. Success will be measured by error reduction, on-time submissions, and a strong culture of accountability. This role requires strong leadership skills and extensive experience in clinical research quality and regulatory affairs.

Requirements

• 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

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

Preferred Qualifications

• Professional certifications (e.g., SOCRA, ACRP, RAC)
• Located in Ann Arbor, Baltimore, Denver, DC, or Nashville