Senior Director, Quality Management Systems & Compliance

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 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
  External Engagement & Industry Leadership
• 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

About You:

• 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
• Prolonged periods of sitting at a desk and working on a computer.

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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 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.