Intellia Therapeutics

Senior Director Quality Assurance Systems and Compliance

Location
Cambridge, MA
Posted
Jul 02, 2022
Ref
R694
Required Education
Bachelors Degree
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 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 exciting key leadership role within our growing quality organization will support our expanding clinical pipeline. If you are a strategic leader who loves building and mentoring a team, thrives in a collaborative environment, and are interested in establishing quality systems to support multiple modalities in the cell and gene space, this role is your role! This is a unique opportunity to drive the strategic maturity of Intellia’s GXP quality systems and digital compliance.

In this role you will:

  • Work with leadership teams, internal functional management, and external regulatory bodies to ensure we sustain the current and anticipated levels of quality standards.

  • Partner will Digital Compliance leadership on the development of lifecycle policies and procedures related to computer software assurance/validation to ensure global regulatory requirements are achieved in Intellia’s digital solutions and technologies.

  • Develop and report on quality performance metrics

  • Participate in building, deploying, managing, and training of quality system processes

  • Be responsible for maintaining and continuous improvement of the GXP QMS programs.

  • Manage internal and vendor audit programs

  • Establish and manage the Risk Management program

  • Perform Regulatory Compliance Surveillance

  • Manage Inspection Readiness and Inspection Management

About You:

  • Expert knowledge of US, EU, and ICH regulations and guidance documents

  • Confirmed leadership in implementing Quality Management Systems

  • Knowledge and competence in Quality processes, including change control, discrepancy, CAPA, risk management, and training.

  • Bachelor's degree in life-scientific discipline

  • 12+ years of experience working in the biopharmaceutical GMP functions

  • Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical development environment.

  • Proven team leader with a track record of influencing/building/promoting a quality culture.

  • Proven ability to design/evolve and implement quality strategies with operational planning and oversight.

  • Experience in Cell and Gene Therapy Product

  • Experience in hosting and managing Regulatory Inspections

Meet your future team:

You will be joining a dynamic growing team who are passionate about quality and patient centric. Intellia’s quality group is a young organization having grown quickly during the last two years in order to support bringing previously contracted capabilities in-house. Joining our team, you will have the opportunity to help build the quality systems and compliance group while leveraging the strong committed team currently in place. 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.