Vice President, Quality Management Systems and Digital Compliance (Somerville)

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:The Vice President of Quality Management Systems is responsible for defining and executing the enterprise-wide quality vision that enables organizational growth from clinical development through commercial operations. As a transformational leader and executive sponsor for quality system modernization, this position drives digital transformation through eQMS implementation, establishes robust governance frameworks, and ensures sustained regulatory compliance and inspection readiness. The Vice President of Quality Systems and Digital Compliance will own the strategic vision for data integrity and governance programs including AI/ML quality applications and digital innovation. This role will develop and lead a high-performing quality team focusing on a culture of quality excellence and serve as a strategic partner to executive leadership across R&D, Manufacturing, Regulatory Affairs, and Commercial Operations. This executive role anticipates regulatory trends, manages enterprise risk, and positions quality as a competitive differentiator that directly contributes to business value and organizational success in bringing life-changing therapies to patients.Responsibilities:Enterprise QMS Strategy & VisionDefine and execute enterprise-wide QMS strategy aligned with corporate objectives and growth plansServe as executive sponsor for quality system transformation initiatives supporting commercialization readinessLead long-term strategic planning for quality infrastructure investments, technology roadmaps, and organizational capability buildingAnticipate regulatory trends and proactively position the organization to meet evolving compliance requirementsChampion quality excellence as a competitive differentiator and driver of business valueOrganizational Leadership & TransformationLead enterprise-wide quality transformation and change management initiatives, driving cultural change and operational maturityEstablish governance structures, decision-making frameworks, and accountability models across the quality systemBuild organizational consensus on quality priorities and resource allocationRepresent Quality in executive forums, strategic planning sessions, and board presentationsQMS Architecture & ImplementationDesign, implement, and scale comprehensive quality systems from clinical through commercial stages, with focus on advanced therapy medicinal products (ATMPs)Establish QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company policiesOwn the Quality Management System strategic roadmap with multi-year planning horizons supporting pipeline expansion and future innovationsQuality Systems Management & GovernanceProvide executive oversight for critical quality processes including Deviations, CAPA, Change Control, Document Control, Complaints, Quality Risk Management, and Data Integrity programsChair Quality Management Review processes, presenting system metrics, trends, and strategic recommendations to executive leadershipEstablish quality intelligence and analytics capabilities to drive data-informed decisionsDrive continuous improvement initiatives and define KPIs that measure quality system performance and business impacteQMS Implementation & Digital Compliance LeadershipLead enterprise digital transformation through adoption, validation, and optimization of electronic Quality Management Systems (eQMS)Oversee IT Quality, Computer System Validation (CSV), and Data Integrity programs ensuring compliance with 21 CFR Part 11, Annex 11, and GAMP 5Champion strategic vision for Data Governance & Integrity programs, including AI/ML quality applications and digital innovationPartner with IT leadership on GxP computer systems lifecycle compliance and drive investment decisions for quality technology stackInspection Readiness & Regulatory ComplianceEnsure enterprise-wide readiness for global regulatory inspections and Pre-Approval Inspections (PAIs)Lead critical health authority inspections and third-party GMP auditsSupport regulatory submission strategies and authoring of product licenses and regulatory dossiersEnterprise Risk Management & Operational EffectivenessEstablish enterprise risk management framework integrating quality risk into corporate risk management processesDefine enterprise quality metrics and drive operational effectiveness through data analyticsChampion quality by design (QbD) and risk-based thinkingDevelop and oversee risk-based approaches for quality system governanceEnsure proactive identification and mitigation of compliance risksDefine 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-makingTeam Leadership & Talent DevelopmentBuild, develop, and lead a high-performing organization of quality professionalsFoster a culture of accountability, innovation, and continuous improvementProvide executive coaching and mentorship to quality leadersChampion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisitionCross-Functional Executive PartnershipsServe as strategic partner to R&D, Technical Operations, Supply Chain, Regulatory Affairs, and Commercial Operations leadershipCollaborate with Legal, Finance, and Corporate Development on compliance risk management, due diligence, and integration activitiesPartner with Human Resources on quality training strategy, organizational design, and change managementBuild external relationships with industry associations, regulatory agencies, and peer organizationSupervisory ResponsibilitiesBuild, develop, and lead a high-performing organization of quality professionalsFoster a culture of accountability, innovation, and continuous improvementProvide executive coaching and mentorship to quality leadersChampion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisitionProvides constructive and timely performance evaluations.About you:Expert-level knowledge of global health authority regulations including FDA, EMA, PMDA, and ROW requirements for pharmaceuticals and ATMPsDeep expertise in ICH guidelines (Q8, Q9, Q10, Q11), 21 CFR Part 11, EU GMP Annex 11, and emerging regulatory frameworksProven expertise leading digital transformation initiatives including eQMS implementation, validation, and optimizationStrong knowledge of Computer System Validation, data integrity, and digital compliance requirementsUnderstanding of quality requirements across multiple product types (biologics, ATMPs) preferredAdvanced expertise in quality management methodologies including Lean Six Sigma (Black Belt preferred), FMEA, Root Cause AnalysisStrong proficiency with data analytics, business intelligence tools, and quality metrics dashboardsUnderstanding of emerging technologies including AI/ML applications in quality, digital twins, and predictive analyticsKnowledge of industry risk management concepts and their application to quality managementBS, MS, or PhD in a field of science, engineering, pharmacy, or medicine.15-20+ years quality leadership in Cell & Gene Therapy, biotech, or pharmaceutical industry with 10+ years managing quality systems and compliance functionDirect experience leading multiple successful regulatory approvals and commercial launchesExpert knowledge of FDA, EMA, and global health authority regulationsProven track record leading regulatory inspectionsExtensive experience implementing enterprise-wide eQMS and digital transformation initiativesDemonstrated success scaling quality organizations from clinical through commercial phasesStrategic business acumen to translate quality into competitive advantageAbility to lead organizational transformation and drive cultural changeExecutive presence with proven ability to influence across all organizational levelsExperience managing quality teams through high-growth environmentsDeep knowledge of ICH guidelines, 21 CFR Part 11, EU GMP Annex 11Strong expertise in data integrity, Computer System Validation, and digital complianceAdvanced quality methodologies (Lean Six Sigma, FMEA, Root Cause Analysis)Experience with emerging technologies (AI/ML in quality, predictive analytics)#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