Establish strong partnership with senior leaders and key stakeholders, fostering a commitment to quality and a culture of quality. Interface with key external Quality organizations for development vendors and partners.
Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
Assist in the implementation of compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies and marketed products.
Serve as a resource to global clinical and safety personnel on compliance issues, preparations for external inspections, regulatory risk, and process improvement opportunities. Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
Review regulatory and corporate compliance risks and escalating when warranted.
Assure global regulations are followed for clinical trial reporting, including submission of adverse events/SAE reporting and all required clinical reports.
Assure personnel, documentation (protocols, reports), processes and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines.
Develop quality metrics and reporting systems to keep senior management informed of compliance status, critical issues, and corrective actions for risk mitigation.
Assure the quality and
Additional Information
Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just "treat" people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How You Will Achieve More:
We are seeking a strategic and hands-on Senior Director, Good Clinical Practices (GCP) to serve as the enterprise leader responsible for establishing, implementing, and leading a comprehensive global GCP quality framework across Intellia Therapeutics' active clinical development portfolio. Operating at the critical intersection of strategy, execution, and transformation, this role will drive the design and continuous evolution of a modern, risk-based, and inspection-ready GCP quality ecosystem that enables speed, compliance, and innovation. As a key member of the Quality leadership team, the Senior Director will lead cross-functional alignment, influence senior stakeholders, and embed a proactive quality culture that scales with the organization's growth, pipeline expansion and commercialization. This individual will serve as the internal subject matter expert providing GCP and GLP oversight for Intellia, our CROs, and Investigator Sites, while partnering with senior management to develop phase-appropriate, risk-based strategies that ensure clinical trials and post-approval activities meet all applicable regulations, ICH guidelines, and industry best practices. The ideal candidate operates both strategically and tactically, leading organizational change, driving inspection readiness, and building sustainable compliance systems aligned with corporate growth objectives.
Intelliatx · Cambridge, MA