Senior Director, Quality Management Systems & Compliance

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 an experienced QMS and Digital Compliance Senior Director to lead transformational change within our quality compliance organization. This leadership role is responsible for driving the organization from its current state to a desired future state while maintaining and enhancing quality excellence throughout the transformation process. The role requires setting strategic direction, leading cross-functional partnerships, maturing the quality management system and digital compliance footprint to support commercialization and managing a high performing team of quality professionals. This role offers the opportunity to continue to grow and influence Intellia’s quality culture while leading a world-class team in a dynamic, innovative environment.Responsibilities:Strategic Leadership & TransformationSet overall strategic direction for the quality management system and digital compliance initiativesLead capacity planning for capabilities required to support growth strategies and pipeline expansionPrepare the organization for future innovations and commercial product expansionPlay a leading role in Quality governance processes to support enterprise objectivesQuality Management System (QMS) GovernanceEstablish and maintain a comprehensive global QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company policiesDevelop and implement GxP standards, procedures, and best practices across all modalities (cell and gene) and geographiesProvide strategic oversight for global quality systems including Management Review, Management Notification, Trending, Quality Planning & Continuous Improvement, Material Review Boards, Complaints and recall processes.Own Global Standards, Processes, Practices, Training programs, and implementation tools designed to meet regulatory, industry, and company expectationsRisk Management & ComplianceDevelop and oversee risk-based approaches for quality system governanceEnsure proactive identification and mitigation of compliance risksMonitor regulatory trends and implement proactive compliance measuresServe as subject matter expert for inspection readiness and directly interact with Health Authorities during inspectionsDraft responses to regulatory observations as neededPerformance Management & AnalyticsDefine common global effectiveness and efficiency metrics to drive end-to-end performanceImplement key performance indicators (KPIs) to monitor QMS effectiveness and enable data-driven decision-makingGenerate and evaluate quality system health across all modalities, GxP areas, and geographiesMonitor performance metrics and provide insights to inform strategic decision-makingDrive continuous improvement initiatives leveraging data analytics and metrics​Technology & Systems LeadershipAct as leader and SME for supporting IT applications and analytical toolsPartner with IT and systems owners to ensure 21 CFR 11/Annex 11/GAMP 5 compliance for GxP computer systems lifecycleEnsure systems are configured and maintained to support business needs and facilitate accurate reporting and analyticsTeam Leadership & CollaborationDevelop, lead, mentor, and maintain a community of cross-functional subject matter expertsFoster collaboration on improvement initiatives and deepen organizational knowledge of processes and toolsLead cross-functional teams to drive harmonization of governance processesFoster a robust compliance mindset and culture of quality excellence throughout the organizationManage product complaint handling activities teamExternal Engagement & Industry LeadershipActively engage with external organizations and industry groups to monitor policy changes in regulatory environmentsRepresent the organization in industry forums related to quality management systemsAbout You:Deep knowledge of GxP regulations, QMS frameworks, and regulatory requirements across multiple modalitiesProven track record of leading organizational transformations.Strong analytical and strategic thinking capabilitiesExperience with regulatory inspections and Health Authority interactions.Excellent leadership and cross-functional collaboration skillsExperience across multiple therapeutic modalities (small molecule, cell and gene therapy)Global experience with various regulatory agencies (FDA, EMA, etc.)Advanced knowledge of data analytics and performance management systemsBS, MS, or PhD in a field of science, engineering, pharmacy, or medicine.15+ years of experience in the pharmaceutical industry with quality compliance leadership experience across research and development, commercial manufacturing, pharmacovigilance, information qualityProlonged periods of sitting at a desk and working on a computer.#LI-RemoteEEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.The base salary for this position is expected to range between $251,771.00 - $307,721.00 USD per year.The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.For more information about Intellia’s benefits, please click here.SummaryLocation: Cambridge, MAType: Full time