What are the responsibilities and job description for the Director, Standards and Compliance position at Intellia Therapeutics?
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.
Director, Standards and Compliance
As Director, Standards and Compliance within the Development Operations organization, you will be supporting the Development Operations Leadership Team and Development Operations / Clinical Operations Infrastructure. This is a key member of the Development Operations team and will partner closely with the Clinical Operations, R&D Medicine, Biometrics, Drug Safety & Pharmacovigilance (DSPV), Information Technology (IT), and the Intellia Quality organizations to build and support activities related to compliance and operational excellence.
Duties / Responsibilities
- Coordination of activities related to Development controlled documents (policies, procedures, forms, etc.) to confirm consistency with regulations, Intellia processes, industry standards and to support inspection readiness.
- Lead internal assessments of compliance with external and internal standards while working with key stakeholders to create processes and documentation of requirements.
- Support Clinical Operations (e.g. Clinical Leads) related to compliance requirements with vendors (e.g. CROs) and other operational processes as appropriate.
- Coordinate with key stakeholders to develop, assign and implement requirements related to Development infrastructure while supporting training and compliance requirements for Development Organization.
- Lead and participate in strategic discussions and initiatives related to Issue and Risk oversight, management and resolution with relevant key stakeholders.
- Identify innovative and robust processes and tools to enhance compliance and documentation of regulated processes.
- Support the direction to the organization in ensuring inspection readiness of the organization, its vendors, and its clinical investigators / sites in conjunction with Clinical Operations, Clinical Quality and other applicable functions.
- Support a culture of continuous improvement, enhanced compliance and performance excellence; act as a change champion and effectively lead change.
- Maintain awareness of biopharmaceutical business, operational trends, and external organizational developments to help define future strategic direction.
- Provide leadership in a highly matrixed environment and assist in mentoring Clinical Operations team members.
Supervisory Responsibilities
Role may be required to manage people.
Requirements
Skills / Abilities
Education / Certifications
BA / BS in related discipline; advanced degree preferred
Experience
10 years) experience with a CRO or biopharmaceutical company with strong knowledge associated with GCP and inspection readiness activities
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer
Manual dexterity for keyboarding; may include repetitive movements.
Covid-19 Vaccination Policy : All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.
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.