Clinical QA 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:

We are excited to welcome the Clinical QA Lead to our growing team and company. This is both a strategic and hands-on role. As the Clinical Lead, you will work on various clinical projects with responsibilities including but not limited to:

• Preforming GCP/GLP/PV Vendor Qualification process as per procedure.
• LeadingGCP/GLP/PV External and Internal Audit schedule.
• Tracking audit report completion, audit responses from vendors, and any remaining open observations via a CAPA to closure.
• Interacting with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups as well as assists in the drafting of audit plans, confirmation letters and agendas, etc.
• Collaborating with cross-functional departments to ensure timely implementation of document change requests.
• Participating in regulatory inspections to assure timely retrieval of documents.
• Reviewing or revising Clinical SOPs to assess consistency and compliance with regulatory requirements/internal standards

About You:

If you have proven clinical quality experience, and are agile with attention to detail, this is the role for you! We are looking for a problem-solver, who enjoys cross-functional partnerships. You will have a bachelor's degree in a scientific field, with a minimum 8 years of relevant biopharmaceutical industry experience in GCP/GLP Quality Assurance. This role will also require some travel, up to 10%.

Meet your future team:

The Quality team provides expertise and technical support on compliance matters to partners both within the organization as well as externally. This highly collaborative team is comprised of various Quality Assurance functions including compliance/operations, documentation, training, Clinical QA, and computer system validation. You will report to the Senior Manager, Clinical Quality Assurance. The Clinical Quality Assurance (CQA) team is an independent compliance team responsible for ensure that the performance, data, documentation, and reports are in compliance with Good Clinical Practice (GCP) and applicable regulatory requirements across each of our clinical programs.

We are currently working virtually, though we plan to return to our Cambridge, MA office in September (tentatively). The ideal candidate should be local or willing to relocate. 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.

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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.