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 Manager, GLP and Clinical Bioanalysis to our growing Clinical Quality Assurance (CQA) team and company. This is both a strategic and hands-on role. As the Manager, GLP and Clinical Bioanalysis, you will support various programs with responsibilities including but not limited to:
- Performing GLP/GCLP Vendor Qualification process as per procedure.
- Performing review of Bioanalytical development assays, validation, and sample analysis to support pre-clinical and clinical programs (PK, PD, ADA, MRD, immunogenicity, and additional biomarkers for efficacy and safety by mass spec, PCR, ligand binding assays (LBA), and cell/flow cytometry methods.
- Non-clinical regulatory filing enabling studies and GLP studies.
- Auditing studies, systems, processes, facility, and vendors GLP and GCLP, bioanalytical laboratory, central laboratory, and clinical site (GCP) audits per the audit plan, and authoring audit reports
- Contributes to the GLP/GCLP annual audit strategy for research and development.
- Conducts and/or oversees the planning, conduct, approval, and close-out of internal and external audits.
- Leads GLP inspection readiness activities and end-to-end inspection execution. Supports a cross-functional inspection team of quality representatives, process owners and subject matter experts (SMEs).
- Coordinate trainings for GxP compliance and activities for inspection readiness for filing for market approval.
- Collaborate with various functional groups (Clinical, Early Development, Clinical Operations, and Regulatory).
- Participates in CAPA management process including direct or indirect implementation of actions resulting from observations/quality issues, reviewing and approving CAPA responses, etc.
- Serves as an independent point of quality escalation to the business and maintains a holistic view of GLP quality by identifying, assessing, advising on, and overseeing mitigation of impactful quality risks, providing input into quality needs / actions.
- Provides subject matter expertise in the development and review of procedural documents related to audit, CAPA and Quality Issue Management, data integrity, quality risk management, observational trend analysis, etc.
- Contributes to identification of relevant GxP trends and supports process improvement initiatives to implement process changes to address any gaps or inefficiencies
If you have demonstrated quality experience, and are agile with attention to detail, this is the role for you! We are looking for a problem-solver, able to work independently and 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 GLP Quality Assurance. Understanding of pre-clinical and clinical regulatory guidelines of USA (FDA), EU (EMA & MHRA), ICH Guidelines, OECD, GLP, CLIA, 21CFR Part11 and general compliance and audit concepts. This role will also require up to 10% travel.
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.
We are currently working virtually, though plans are to return to our Cambridge, MA offices in the near future. 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.
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.