How you will Achieve More with Intellia:

The Director, GCP and GVP Quality Assurance will serve as a strategic leader in the development, implementation and management of quality and compliance to ensure clinical and pharmacovigilance related activities are conducted in accordance with applicable global regulations. The individual will partner with stakeholders to develop a phase and systems-appropriate quality strategy to support Intellia’s pipeline. The Director, GCP and GVP Quality Assurance will work independently and as an effective and engaged team member in a fast-paced environment. This position requires a balanced approach to developing and executing GCP and GVP operations while working in a collaborative manner with peers across departments.

Responsibilities:

• Proactively provide consultative GCP/PV QA support to Clinical Development activities to protect patient safety, maintain data integrity, and support operational efficiency.

• Assure global regulations are followed for clinical trial / product reporting, including submission of adverse events/SAE reporting and all required clinical reports.

• Assist in the implementation of GCP and GVP compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies and marketed pharmaceutical/medical device combination products.

• As a strategic partner, serve as a resource to global clinical and safety personnel on compliance issues, risk management activities, preparations for external inspections, regulatory risk, and process improvement opportunities and develop and oversee appropriate Quality metrics and reporting on the state of Intellia’s compliance to senior management regarding critical quality and compliance related issues and corrective actions to mitigate risk.

• Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections internally, at clinical sites, and at CROs, including follow-up efforts, to ensure successful outcomes and responses to any observations.

• Manage CQA staff, including recruitment, performance management, hiring, training and development and sit on the R&D Quality Leadership team.

About you:

Are you a motivated leader with organizational skills and drive? Our ideal candidate is someone with experience in risk-based GCP/GVP compliance programs and who thrives in an environment with an ability to shape an evolving program in support of this expanding team with:

• BS/MS degree in a related scientific field with 15/10 years, respectively, of relevant experience in the biopharmaceutical/pharmaceutical industry with specific focus in a GCP / GVP quality related discipline or equivalent combination of education/experience.

• Strong understanding of GCP (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive).

• Understanding of GVP (e.g., European Union Directive 2010/84/EU and current modules).

• Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.

• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines with the ability to influence people at different levels.

• Ability to build and sustain meaningful relationships with business stakeholders and partners.

Position may require up to 20% domestic/international travel.

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 that has grown quickly during the last two years to support previously contracted capabilities moving in-house. Joining our team, you will have the opportunity to advance the Clinical Quality Assurance program. 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, 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.