Specialist, Supplier Quality

Cambridge, MA, United States
Oct 15, 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 contract opportunity for a Specialist, Supplier Quality. In this role, you will assist with the oversight of the supplier quality program. In addition, to performing day to day program activities, you will act as interdepartmental liaison to various groups including Process Development, Analytical Development, Supply Chain, and Quality Control.

    • Perform activities related to the supplier quality program, including external audits, supplier lifecycle management, performance monitoring and audits
    • Support the management of the supplier audit schedule, including consultant activities
    • May perform audits of external suppliers including audit preparation activities, and report generation
    • Maintain Quality Agreements between Intellia Therapeutics and external parties
    • Assist with supplier risk assessments
    • Manage activities related to the Supplier Change Notification and Supplier Corrective Action Reporting processes
    • Assist in the maintenance of the approved supplier list
    • Participate on contract organization project teams as required
    • Assist in the implementation of GxP quality standards, policies and procedures
    • Participate as SME in internal audits as required
    • Prepare metrics for presentation to management

    • BS in a related scientific field with 5+ years of Quality experience in a GMP regulated environment
    • Working knowledge of regional regulatory requirements specific to GMPs (e.g. FDA, EU)
    • Previous supplier quality program experience
    • Previous contract manufacturing operations and contract laboratory service experience
    • Experience at working both independently with minimal supervision and in a team-oriented, collaborative environment
    • Proficiency in MS Office applications (Word, Excel, PowerPoint, Project) and Quality System Databases
    • Travel Requirements 0-10% (domestic)
    • Experience working with electronic quality systems (e.g. Veeva, LIMS) (preferred)
    • Participation in supplier audits or internal audits (preferred)


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 minds...free 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.

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