Director, Quality Assurance

Location
Cambridge, MA, United States
Posted
Mar 18, 2021
Ref
R125
Hotbed
Genetown
Required Education
Other
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:

We are excited to add this new role to our growing team and company. This is both a strategic and hands-on position. If you have proven Quality Assurance leadership experience in a cGMP environment, strong knowledge of FDA and EMA regulatory requirements along with solid prioritization and problem-solving skills, this is the role for you! As the Director, Quality Assurance, you will perform various activities including:
  • Leading and mentoring the Quality Assurance Compliance, Document Control/Training and Computer Systems Validation team members
  • Developing phase-appropriate quality management systems for each stage of the product lifecycle, according to regulatory requirements
  • Assessing internal activities for compliance to cGMP, identifying any areas of non-compliance, and leading implementation of solutions
  • Collaborating with management team members to establish quality standards
  • Providing QA compliance support for internal and external projects and programs
  • Overseeing lot disposition of drug substance and drug product batches
  • Supporting regulatory submission document review
  • Implementing performance metrics to evaluate organizational performance and trends
  • Achieving financial objectives by preparing the quality assurance budget and analyzing variances


This position does require a bachelor's degree in a scientific field, with a minimum of 15 years' relevant biopharmaceutical industry experience in Quality functions. Ideally, your people-management experience includes direct reports at the manager and associate director levels. 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. You will have strong leadership qualities including strategic thinking, innovation, mentoring and collaboration. Experience with electronic document, 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 Senior Director, 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, tentatively we are scheduled to return in June 2021. 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.