Senior Manager, Clinical 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 wantall ofour 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 role within our growing quality organization will support our expanding clinical pipeline. If you are a strategic leader who thrives in a collaborative environment and is passionate about quality and patient safety, this role is your role! This is a unique opportunity to develop and implement quality standards, policies, and procedures in compliance with applicable ICH-GCP regulations and guidelines for multiple types of modalities in the cell and gene space. In this role you will:

• Provide compliance support for activities at clinical sites including issue resolution, impact assessment and inspection readiness

• Collaborate with cross-functional teams, provide guidance and effective partnership to meet business priorities and its applicability for adequate quality oversight

• Manage supplier quality-related activities, including external compliance and audit support of CROs, specialty laboratories for Phase I-III programs

• Provide internal audit support related to systems, documents and functions

• Assist in establishing the organizational structure for the Clinical Quality Assurance function

• Prepare quality metrics for presentation to management

• Participate in the budget planning process for Quality Assurance

About You:

• BS/MS degree in a related scientific field with 8+/5+ years, respectively, of relevant experience in the biopharmaceutical/pharmaceutical industry

• Previous Quality Assurance experience (5+ years) in clinical research /development preferred with a minimum of 3 years of Quality Assurance auditing experience

• Experience in developing/implementing Clinical Quality Assurance procedures

• Strong knowledge of global GCP regulations, guidances and standards

• Ability to analyze issues and resolve in a compliant manner

• Experience in GLP oversight is a plus

• Experience with eQMS is a plus

• Travel requirement: 0-20%

Meet your future team:

Our quality team is a young organization having grown quickly during the last two years to support the multiple cell and gene programs in our advancing pipeline. You will report to the Senior Director, GCP & GVP Quality Assurance. This opportunity offers a remote-friendly work environment with a readiness to travel on-site to meet business objectives. You can expect to join a hardworking, collaborative environment!

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.