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Manager, Clinical Quality Assurance

Company: Intellia Therapeutics
Location: Brookline
Posted on: September 9, 2020

Job Description:

At Intellia, we are revolutionizing medicine by harnessing the power of genome editingto develop potential cures. We bring new hope for people living with conditions including cancer, genetic disorders, viral infections, inflammatory disorders and many more.Intellia Therapeutics has an exciting new opportunity for a Clinical Quality Assurance Manager/Senior Manager. In this role you will support the implementation of GCP and the management of clinical quality related activities. You will also support the audit program and will act as a liaison to cross-functional groups including Clinical Development and Regulatory Affairs.Responsibilities:Assist in the development and implementation of GCP quality standards, policies, and procedures.Provide compliance support for activities at clinical sites including issue resolution and impact assessmentManage supplier quality related activities, including external compliance and audit support of CROs, specialty laboratories and Phase I unitsProvide internal audit support related to systems, documents and functionsAssist in establishing the organizational structure for the Clinical Quality Assurance function Coordinate, develop and/or provide training as requiredPrepare quality metrics for presentation to managementParticipate in the budget planning process for Quality AssuranceOther projects as assigned Qualifications:BS in a related scientific field with 8+ years of relevant experience in the biopharmaceutical/pharmaceutical industryPrevious Quality Assurance experience (5+ years) in clinical research /development preferredMinimum of 3 years of Quality Assurance auditing experienceExperience in developing/implementing Clinical Quality Assurance proceduresStrong knowledge of global GCP regulations, guidances and standardsExperience at working both independently with minimal supervision and in a team-oriented, collaborative, environmentAbility to analyze issues and resolve in a compliant manner Effective writing and oral presentation skills.Proficiency in MS Office applications (Word, Excel, PowerPoint, Project)Experience in GLP oversight is a plusExperience with eQMS is a plusTravel requirement: 0-20%#LI-KO1What Intellia Stands For:At Intellia, our mission is to develop potentially curative genome editing treatments that can positively transform the lives of people living with severe and life-threating diseases. We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us trusting and counting on every single one of us. - Explore because we seek new ways to tackle disease. Explore with unbounded mindsfree from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways. - Disrupt by thinking courageouslyand creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughtswith that breed of skepticism that shows you have better solutions. - Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standardseven when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done. POSITION: Full-Time, Exempt 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.Intellias web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Levers privacy policy.130 Brookline St. Cambridge, MA 02139 /Development Quality /Full-time

Keywords: Intellia Therapeutics, Brookline , Manager, Clinical Quality Assurance, Executive , Brookline, Massachusetts

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