Manager, Computer Systems Validation

Cambridge, MA, United States
Nov 13, 2020
Required Education
Bachelors Degree
Position Type
Full time
Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

Intellia Therapeutics has an exciting new opportunity for a Computer Systems Validation Manager/Senior Manager. In this role you will provide Quality oversight of the validation activities for the GxP computerized systems as well as applicable instrumentation. You will also support computerized system lifecycle activities and ensure compliance with relevant guidance's and regulations. This role will act as a liaison to cross-functional groups including Information Technology, Clinical, Manufacturing, and Regulatory Affairs.

    • Provide Quality oversight of GxP computerized systems and applicable instrumentation
    • Review/approve validation documentation including validation plans, protocols, test scripts, and summary reports
    • Evaluate computerized system lifecycle requirements and manage exceptions and changes utilizing the Quality Management System
    • Perform Data Integrity assessments on new and existing systems
    • Assist in the development and implementation of departmental policies and procedures
    • Provide internal audit support related to systems, documents and function
    • Participate in risk assessments for computerized systems
    • Assist with supplier quality related activities of external organizations as applicable
    • Coordinate, develop and/or provide training
    • Participate in the budget planning process as required
    • Other projects as assigned

    • BS in a scientific field or IT related discipline with 8+ years of relevant experience in the biopharmaceutical/pharmaceutical industry (or equivalent education and work experience)
    • Minimum of 5 years of experience in Quality oversight of computerized systems validation activities
    • Strong knowledge of GxP guidances and regulations including 21 CFR Part 11, Annex 11, ICH, GAMP5, Data Integrity)
    • Experience with validation testing, including related document generation and approval
    • Experience in developing/maintaining/implementing policies and procedures
    • Experience at working both independently with minimal supervision and in a team-oriented, collaborative environment
    • Ability to analyze issues and resolve in a compliant manner
    • Effective writing and oral presentation skills
    • Proficiency in MS Office applications (Word, Excel, PowerPoint, Project)
    • Experience in validation of manufacturing process and analytical instrumentation preferred
    • Travel requirement: 0-10%

What Intellia Stands For:

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

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.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .