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Quality Assurance:
Senior Director, GCP & GVP Quality Assurance

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 with Intellia:

This exciting key leadership role within our growing quality organization will support our expanding clinical pipeline.  If you are a strategic leader who loves building and mentoring a team, thrives in a collaborative environment and is passionate about quality and patient safety, this role is your role! This is a unique opportunity to oversee GCP/PV quality for multiple types of modalities in the cell and gene space. In this role you will:

  • Provide overall GCP and PV QA leadership and strategic for global GCP and GVP activities at Intellia, its investigator sites and external service providers to ensure collaborative team involvement and implementation of quality and compliance initiatives.

  • Provide strategic leadership in the implementation of risk-based approaches to quality for clinical development programs including application of QbD principles and mechanisms for ongoing quality risk monitoring.

  • Serve as a resource to global clinical and safety personnel on compliance issues, preparations for external inspections, regulatory risk, and process improvement opportunities.

  • Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections internally, at clinical sites, and at CROs.

  • Partner and provide consultative GCP/PV QA support to global clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency.

About You:

  • Expert knowledge in global GCP/PV regulations and experience in interpreting and applying GCP/PV requirements.
  • Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical development environment.
  • Proven team leader with a track record of influencing/building/promoting a quality culture.
  • Proven ability to design/evolve and implement quality strategies with operational planning and oversight.
  • M.S. (or equivalent degree) and 10+ years of relevant work experience or B.S in scientific or allied health field and 15+years of relevant experience.
  • Minimum 5 years team leadership experience.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

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.

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.