Vice President, Quality Management Systems and Digital Compliance

Intellia Therapeutics, Inc.•Cambridge, MA

14d•$319,064 - $389,968•Remote

About The Position

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.

Requirements

Expert-level knowledge of global health authority regulations including FDA, EMA, PMDA, and ROW requirements for pharmaceuticals and ATMPs
Deep expertise in ICH guidelines (Q8, Q9, Q10, Q11), 21 CFR Part 11, EU GMP Annex 11, and emerging regulatory frameworks
Proven expertise leading digital transformation initiatives including eQMS implementation, validation, and optimization
Strong knowledge of Computer System Validation, data integrity, and digital compliance requirements
Understanding of quality requirements across multiple product types (biologics, ATMPs) preferred
Advanced expertise in quality management methodologies including Lean Six Sigma (Black Belt preferred), FMEA, Root Cause Analysis
Strong proficiency with data analytics, business intelligence tools, and quality metrics dashboards
Understanding of emerging technologies including AI/ML applications in quality, digital twins, and predictive analytics
Knowledge of industry risk management concepts and their application to quality management
BS, 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 function
Direct experience leading multiple successful regulatory approvals and commercial launches
Expert knowledge of FDA, EMA, and global health authority regulations
Proven track record leading regulatory inspections
Extensive experience implementing enterprise-wide eQMS and digital transformation initiatives
Demonstrated success scaling quality organizations from clinical through commercial phases
Strategic business acumen to translate quality into competitive advantage
Ability to lead organizational transformation and drive cultural change
Executive presence with proven ability to influence across all organizational levels
Experience managing quality teams through high-growth environments
Deep knowledge of ICH guidelines, 21 CFR Part 11, EU GMP Annex 11
Strong expertise in data integrity, Computer System Validation, and digital compliance
Advanced quality methodologies (Lean Six Sigma, FMEA, Root Cause Analysis)
Experience with emerging technologies (AI/ML in quality, predictive analytics)

Nice To Haves

Understanding of quality requirements across multiple product types (biologics, ATMPs)
Lean Six Sigma (Black Belt preferred)

Responsibilities

Define and execute enterprise-wide QMS strategy aligned with corporate objectives and growth plans
Serve as executive sponsor for quality system transformation initiatives supporting commercialization readiness
Lead long-term strategic planning for quality infrastructure investments, technology roadmaps, and organizational capability building
Anticipate regulatory trends and proactively position the organization to meet evolving compliance requirements
Champion quality excellence as a competitive differentiator and driver of business value
Lead enterprise-wide quality transformation and change management initiatives, driving cultural change and operational maturity
Establish governance structures, decision-making frameworks, and accountability models across the quality system
Build organizational consensus on quality priorities and resource allocation
Represent Quality in executive forums, strategic planning sessions, and board presentations
Design, 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 policies
Own the Quality Management System strategic roadmap with multi-year planning horizons supporting pipeline expansion and future innovations
Provide executive oversight for critical quality processes including Deviations, CAPA, Change Control, Document Control, Complaints, Quality Risk Management, and Data Integrity programs
Chair Quality Management Review processes, presenting system metrics, trends, and strategic recommendations to executive leadership
Establish quality intelligence and analytics capabilities to drive data-informed decisions
Drive continuous improvement initiatives and define KPIs that measure quality system performance and business impact
Lead 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 5
Champion strategic vision for Data Governance & Integrity programs, including AI/ML quality applications and digital innovation
Partner with IT leadership on GxP computer systems lifecycle compliance and drive investment decisions for quality technology stack
Ensure enterprise-wide readiness for global regulatory inspections and Pre-Approval Inspections (PAIs)
Lead critical health authority inspections and third-party GMP audits
Support regulatory submission strategies and authoring of product licenses and regulatory dossiers
Establish enterprise risk management framework integrating quality risk into corporate risk management processes
Define enterprise quality metrics and drive operational effectiveness through data analytics
Champion quality by design (QbD) and risk-based thinking
Develop and oversee risk-based approaches for quality system governance
Ensure proactive identification and mitigation of compliance risks
Define common global effectiveness and efficiency metrics to drive end-to-end performance
Implement key performance indicators (KPIs) to monitor QMS effectiveness and enable data-driven decision-making
Build, develop, and lead a high-performing organization of quality professionals
Foster a culture of accountability, innovation, and continuous improvement
Provide executive coaching and mentorship to quality leaders
Champion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisition
Serve as strategic partner to R&D, Technical Operations, Supply Chain, Regulatory Affairs, and Commercial Operations leadership
Collaborate with Legal, Finance, and Corporate Development on compliance risk management, due diligence, and integration activities
Partner with Human Resources on quality training strategy, organizational design, and change management
Build external relationships with industry associations, regulatory agencies, and peer organizations
Provides constructive and timely performance evaluations.