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
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