Associate Director, Quality Assurance

Location
Cambridge, MA
Posted
Sep 30, 2021
Ref
R371
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

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:

As Associate Director, Quality Operations, your responsibilities will include, but not be limited to:

  • support of CMC development teams in advancing Cell therapy/gene therapy drug candidates;

  • manage timely lot review/disposition of clinical GMP lots

  • identify, assess and manage risks; recommend mitigation strategies to quality management

  • represent Quality on External Supplier project team meetings

  • development, implementation and continuous improvement of procedures, ways of working.

  • support/manage investigations with potential to impact product quality/patient safety;

  • review IND, IMPD, BLA, MAA, RTQ’s, Briefing Books

  • support the accurate/on time development/approval/implementation of change management requests

About You:

Are you a people manager with a Bachelor’s degree in Sciences or Engineering, and 9+ years' biopharma experience? Does your experience include at least five years in Quality Assurance, and prior experience with cell/gene therapy/biologics? If this sounds like you, please consider applying for this role! To be successful in this role, strong written and verbal communication skills are essential. In addition, you'll leverage your leadership skills to innovate, collaborate, and strive for results.

Meet your future team:

You’ll be joining an exceptional team that collaborates with internal stakeholders and external partners to develop innovative therapies which bring hope to patients and their families. You will report to the Director, Quality Assurance. You’ll be supported as you bring your specific talents and suggestions to continuously develop our quality processes and ways of working to allow us to accelerate the progress of our clinical assets through development.

The team is currently working virtually. We do have plans to return to the Cambridge MA office in January 2022 (tentatively). Intellia has led the charge and designed a robust virtual onboarding experience since the start of the pandemic. Although in a virtual environment, the Quality team has made it a priority to continue to foster a sense of community among the group.

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Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. 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.