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Development:
Manager, Clinical Quality Assurance
At Intellia, we are revolutionizing medicine by harnessing the power of genome editing to 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 assessment
- Manage supplier quality related activities, including external compliance and audit support of CROs, specialty laboratories and Phase I units
- Provide internal audit support related to systems, documents and functions
- Assist in establishing the organizational structure for the Clinical Quality Assurance function
- Coordinate, develop and/or provide training as required
- Prepare quality metrics for presentation to management
- Participate in the budget planning process for Quality Assurance
- Other projects as assigned
Qualifications:
- BS in a related scientific field with 8+ years of relevant experience in the biopharmaceutical/pharmaceutical industry
- Previous Quality Assurance experience (5+ years) in clinical research /development preferred
- Minimum of 3 years of Quality Assurance auditing experience
- Experience in developing/implementing Clinical Quality Assurance procedures
- Strong knowledge of global GCP regulations, guidances and standards
- Experience at working both independently with minimal supervision and in a team-oriented, collaborative, environment
- Ability 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 plus
- Experience with eQMS is a plus
- Travel requirement: 0-20%
#LI-KO1
What 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 minds…free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.
- Disrupt by thinking courageously…and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts…with 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 standards…even 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.
Intellia’s web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever’s privacy policy.
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.