Computer Systems Validation Lead

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:

Intellia is growing and we are excited to be expanding our team to include this newly created Computer Systems Validation Lead role. This is both a strategic and hands-on position. You will lead compliance and direct project teams in CSV and Infrastructure Qualification standards and practices. This is accomplished by participating in the delivery of system solutions, developing validation, qualification, migration, or verification strategies for computer systems. You will also promote CSV through project team and stakeholder training with regards to validation, qualification, and verification as needed. Other role responsibilities include but are not limited to:

• Author, review, and approve validation deliverables
• Risk assessments of systems
• Vendor selection and qualification
• Change Controls
• Deviations

About You:

If you have proven Computer System Validation (CSV) experience, knowledge of 21 CFR Part 11, and FDA and EMA regulatory requirements, along with solid prioritization and problem-solving skills, this is the role for you! Our ideal candidate will be able to lead validation work-streams for multiple projects, come up with strategies, work with stakeholders and contribute to the success of Intellia. Additional role requirements include:

• A bachelor's degree in a scientific field, with a minimum of 8 years' relevant biopharmaceutical industry experience in CSV.
• Expertise with quality management systems across all phases of clinical development is required as well as experience with regulatory health authorities (e.g. FDA, EMA).
• Excellent written and verbal communication skills, as well as project management skills, are essential.
• Strong leadership qualities including strategic thinking, innovation, mentoring, and collaboration.
• Experience with electronic documentation, QMS, and learning management systems will be beneficial for this role

Meet your future team:

The Quality team provides technical and compliance support for various departments in the company as well as external organizations. You will report to the Manager, Computer Systems Validation, Quality. This team is comprised of various Quality Assurance functions including compliance/operations, documentation, training and computer system validation. The group is in the process of expanding and collaborates with other aspects of Quality Assurance as well as Quality Control.

The team is currently working virtually. While we do have plans to return into the Cambridge MA office in the future. Although in a virtual environment, the Quality team has made it a priority to continue to foster a sense of community among the group. You can expect to join a hardworking, collaborative environment. Intellia has led the charge and designed a robust virtual onboarding experience since the start of the pandemic.

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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.