Vice President, Quality Management Systems and Digital Compliance

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 & Vision

• 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

Organizational Leadership & Transformation

• 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

QMS Architecture & Implementation

• 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

Quality Systems Management & Governance

• 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

eQMS Implementation & Digital Compliance Leadership

• 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

Inspection Readiness & Regulatory Compliance

• 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

Enterprise Risk Management & Operational Effectiveness

• 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

Team Leadership & Talent Development

• 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

Cross-Functional Executive Partnerships

• 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 organization

Supervisory Responsibilities

• 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
• Provides 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 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)

EEOC 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 $319,064.00 - $389,968.00 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.

Originally posted on Himalayas