Associate Director Quality Assurance External Operations

Company: Intellia Therapeutics
Location: Cambridge
Posted on: May 16, 2022

Job Description:

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 wantall ofour 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:This is a unique opportunity to provide GMP quality oversight for multiple types of cell and gene modalities. This exciting leadership role will oversee a team ensuring CMO manufactured products meet company quality standards and health authority regulations. The Associate Director Quality External Operations is responsible for providing quality oversight of multiple CMO operations covering starting materials through Drug Product Manufacturing. This will also include internal product release as well as coordination of QP release as warranted. In this role you will:

• Mentor and grow your team
• Represents QA in cross-functional project teams such as External Supply Integration, tech transfer, and process improvements.
• Participation and representation of Quality at joint leadership meetings e.g. Operations, Business Review Meetings etc.
• Align philosophies, processes, and policies with the rest of the Quality organization
• Serve as the decision-maker and spokesperson for Quality operational issues related to external manufacturing and distribution sites.
• Provide Quality oversight for the tech transfer of drug substance and drug product from one CMO to another
• Interact on an ongoing basis with both internal and external business partners in Manufacturing/ MSAT/ QSAT/ Technical Development to resolve operational issues.
• Prioritize, direct, and participate in continuous improvement initiatives.
• Direct and provide guidance on Quality matters such as Investigations, CAPAs, technical documents, etc.
• Lead investigation and resolution of cGMP or procedural compliance failures, as well as work CMO site leadership and partners to resolve compliance issues for externally produced products
• Drive the completion and maintenance of CMO/CTO Quality agreementsExperience Required:
  • BS/MS/B.Sc/M.Sc./PhD in the life sciences or engineering.
  • Minimum of 10 years' experience in a GxP environment in the pharmaceutical industry.
  • Thorough understanding of required regulations including but not limited to FDA, PiC/S and European regulation.
  • Strong industry and quality system knowledge (internal and external) experiences within the industry.
  • Significant track record in the gene and cell therapy business.
  • Experience with an autologous cell therapy product.Meet your future team:You will be joining a dynamic growing team who are passionate about quality and are patient centric. Intellia's quality group is a young organization having grown quickly during the last two years in order to support the multiple cell and gene programs in our advancing pipeline. The continued rapid growth of the quality organization, as well as the company, means you will be in a fast-paced dynamic remote friendly work environment with a team that knows how to support it. Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. 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.

Keywords: Intellia Therapeutics, Cambridge , Associate Director Quality Assurance External Operations, Executive , Cambridge, Massachusetts