Sr. Director, R&D Quality and Compliance

Role Summary

Sr. Director, R&D Quality and Compliance at Intellia Therapeutics; provides strategic leadership for the R&D Quality Assurance function ensuring GCP, GVP, GLP, and Research quality oversight across global Phase I–IV studies, with a focus on cell and gene therapy products.

Responsibilities

• Provide overall R&D QA leadership and strategic development for global R&D QA activities to ensure quality and compliance for global Phase I - IV clinical studies and establish phase-appropriate quality systems.
• Partner cross-functionally to escalate and address quality risks, providing risk-based rationale for decision-making and action plans.
• Foster partnerships with senior leaders and external Quality organizations for development vendors and partners.
• Collaborate with Research leadership to drive research quality practices ensuring studies are conducted and data collected in compliance with plans and guidelines.
• Identify and drive continuous quality improvements through audit, inspection, and quality event trend analysis.
• Assist in implementing compliant procedures and a robust quality management system for clinical studies and marketed products.
• Serve as a resource on compliance issues, inspections, regulatory risk, and process improvement; provide guidance and training on GxP regulations.
• Review regulatory and corporate compliance risks and escalate to senior management as needed.
• Ensure global regulations are followed for clinical trial reporting, including adverse event reporting and clinical reports.
• Ensure personnel, documentation, processes, and quality standards meet expectations for regulatory submissions and inspections.
• Develop and oversee Quality metrics and reporting on compliance status and corrective actions.
• Ensure the quality and integrity of results from data protocols and reports in line with regulations.
• Lead preparation and hosting of Health Authority Inspections; oversee inspection readiness for study teams.
• Host GCP and GVP regulatory inspections; manage internal inspection readiness activities across program life cycles.
• Direct internal and external R&D audit programs, including audit plans and prioritization.
• Ensure CROs and vendors comply with quality programs and guidelines.
• Develop and implement Study-Specific Audit Plans and Quality Risk Management Plans for trials.
• Oversee R&D QA incident investigations and CAPA plans with internal and external stakeholders.
• Provide consultative R&D QA support to protect patient safety, data integrity, and operational efficiency.
• Contribute as a member of the Quality Leadership Team; plan resources, culture, talent, and stakeholder engagement.
• Build and develop the R&D QA team; manage staff and budget; recruit and train new personnel; oversee daily workflows and performance evaluations.
• Demonstrate ability to build a high-performing team and handle disciplinary actions per policy.

Qualifications

• Strong understanding of R&D Quality for pre-clinical, clinical, and commercial stages.
• Expert knowledge of global regulations in clinical trials, pharmacovigilance, and product surveillance for cell and gene therapies; GCP expertise (US/EU) including ICHE6, 21 CFR Parts 50, 54, 56, 312, 314, with high-level knowledge of Part 11.
• Experience implementing and ensuring GCP/GVP/GLP quality, including audits, electronic systems management, and inspection readiness.
• Experience leading/regulatory authority inspections and developing responses to findings; proven QRM experience for trials.
• Experience working with CROs and vendors; strong relationship management.
• Strategic planning and execution skills; ability to design/evolve Quality Management Systems in a dynamic environment.
• Knowledge of industry trends and best practices in quality management; excellent communication and ability to foster a culture of quality.

Education

• MS (or equivalent) and 15+ years of relevant experience, or
• B.S. in a scientific or allied health field and 17+ years of relevant experience
• Minimum 15 years of GLP/GCP/GVP quality and compliance management with risk-based direction for development programs

Additional Requirements

• Minimum 10 years of team leadership experience.
• Prolonged periods of sitting and computer work.