Senior Director, Quality Management Systems & Compliance
Intellia TherapeuticsAbout the role
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 & Transformation
- Set overall strategic direction for the quality management system and digital compliance initiatives
- Lead capacity planning for capabilities required to support growth strategies and pipeline expansion
- Prepare the organization for future innovations and commercial product expansion
- Play a leading role in Quality governance processes to support enterprise objectives
Quality Management System (QMS) Governance
- Establish and maintain a comprehensive global QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company policies
- Develop and implement GxP standards, procedures, and best practices across all modalities (cell and gene) and geographies
- Provide 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 expectations
Risk Management & Compliance
- Develop and oversee risk-based approaches for quality system governance
- Ensure proactive identification and mitigation of compliance risks
- Monitor regulatory trends and implement proactive compliance measures
- Serve as subject matter expert for inspection readiness and directly interact with Health Authorities during inspections
- Draft responses to regulatory observations as needed
Performance Management & Analytics
- 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
- Generate and evaluate quality system health across all modalities, GxP areas, and geographies
- Monitor performance metrics and provide insights to inform strategic decision-making
- Drive continuous improvement initiatives leveraging data analytics and metrics
Technology & Systems Leadership - Act as leader and SME for supporting IT applications and analytical tools
- Partner with IT and systems owners to ensure 21 CFR 11/Annex 11/GAMP 5 compliance for GxP computer systems lifecycle
- Ensure systems are configured and maintained to support business needs and facilitate accurate reporting and analytics
Team Leadership & Collaboration
- Develop, lead, mentor, and maintain a community of cross-functional subject matter experts
- Foster collaboration on improvement initiatives and deepen organizational knowledge of processes and tools
- Lead cro
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