Senior Director, Quality Management Systems & Compliance

Intellia Therapeutics, Inc.•Cambridge, MA

4d•$251,771 - $307,721•Remote

About The Position

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.

Requirements

Deep knowledge of GxP regulations, QMS frameworks, and regulatory requirements across multiple modalities
Proven track record of leading organizational transformations.
Strong analytical and strategic thinking capabilities
Experience with regulatory inspections and Health Authority interactions.
Excellent leadership and cross-functional collaboration skills
Experience 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 systems
BS, 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 quality

Responsibilities

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
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
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
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
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
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 cross-functional teams to drive harmonization of governance processes
Foster a robust compliance mindset and culture of quality excellence throughout the organization
Manage product complaint handling activities team
Actively engage with external organizations and industry groups to monitor policy changes in regulatory environments
Represent the organization in industry forums related to quality management systems