Senior Manager, Quality Systems Administrator 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.

How You Will Achieve More With Intellia:

This role will serve as the Quality Business systems administrator for Veeva Quality Vault. You will own and manage the electronic Quality Management System (Veeva Quality Vault) as it relates to the configuration, implementation, analysis as well as the on-going maintenance of the Veeva Quality Vault to maintain compliance with regulatory requirements. Your responsibilities also include the logistical management and support of audits and inspections. This is both a hands-on and strategic role for ensuring the quality of systems, enabling and facilitating compliance with applicable regulations (FDA, EU and other countries) as well as the company’s own policies and procedures.

Systems administration:

• Function as the overall Business system administrator for Veeva Quality Vault and Intellia Therapeutic’s internal audit application.
• Lead implementation, administrative and maintenance activities for Veeva Quality Vault. This includes sitewide training, troubleshooting, end-user support and consulting with software vendor(s).
• Ensure that best practices in feature configuration and overall platform management are adhered to. Ensure that solutions are well engineered, operable, maintainable, documented and aligned with overall business needs
• Participate in efforts to optimize, redesign or modify the Veeva Quality Vault platform in coordination with business improvement initiatives
• Perform regular system reviews with relation to overall security, active users, document control/management, and release management
• Ensure Quality Vault remains compliant as a Validated Solution through verification testing, documentation, and validation efforts
• Review and/or execution of validation documents, including user requirements, test scripts, validation plans/reports, and change management
• Participate in efforts to optimize, redesign or modify the Veeva Quality Vault platform in coordination with business improvement initiatives
• Manage advanced configuration changes for Vault Quality
• Collaborate with stakeholders across Quality, Compliance, IT Architecture teams to prioritize req Ensure Quality Vault remains compliant as a Validated Solution through verification testing, documentation, and validation efforts
• Provide Product expertise in the Veeva Vault QMS platform
• Developing, continuously leading improvement efforts toward continuous Quality improvements and implementing procedures related to Quality Systems Management
• Develop and maintain tools to track metrics for quality management systems health to support quality management reviews.
• Provide trend analysis and key quality metrics to be reported at quality management reviews .
• Track and manage periodic review for training and documentation
• Maintain clear documentation and communication regarding integration processes, workflows, and troubleshooting guides

Audit Management:

• Manage the creation and implementation of audit application software
• Lead audit backroom logistics. This includes sitewide training, troubleshooting, end-user support with the audit application software
• Provide backend audit app and logistical support for partner and regulatory audits.
• Leading continuous improvement efforts and maintenance support for Intellia’s internal audit application
• Coordinate the pre-audit activities with functional groups
• Provide audit metrics: Monitoring, Auditing and Data Analytics

Supervisory Responsibilities:

• Train QA team members and GxP personnel on Veeva workflows and audit applications, processes and requirements.
• Oversees the daily workflow of the department.
• Opportunity to supervise a team is expected as business need increases

About You

• Bachelor’s degree in life sciences or comparable experience
• Minimum 10 years’ GxP QA experience
• Working knowledge of QA principles and GxP guidelines
• Ability to understand and successfully execute detailed written instructions
• Demonstrate accountability, dedication to quality, and attention to detail
• Proficiency using MS Office (advanced user in MS Word preferred)
• Proficiency Veeva Learning Management System (LMS), Veeva QualityDocs (EDMS) and Veeva QMS
• Proficiency Smartsheet
• Proficiency Visio
• Must foster a continuous improvement mentality in support of the Quality Management Team
• Exceptional oral and written communication skills to effectively interact with all levels of the organization to determine training needs
• Must be highly organized and customer service oriented
• Completes routine tasks with minimum supervision. Requires moderate direction to complete more complex tasks

#LI-KO2

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.