Supplier Quality Systems Lead

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:

As Intellia’s Supplier Quality Systems Lead, you will be instrumental in establishing a robust supplier quality system that continually evolves to meet the needs of internal and external stakeholders challenged with global supply of late-stage clinical and commercial drug product. The Supplier Quality Systems Lead will be responsible for launching and maintaining electronic supplier quality workflows, establishing supplier performance monitoring requirements, and working with stakeholders to identify/remediate supplier risks systematically through use of statistical methods and process excellence tools

In this role, you will:

• Establish and manage Supplier Quality workflows in Veeva
• Develop and implement supplier quality performance scorecards
• Manage Supplier Change Notification and quality notifications to suppliers
• Manage SCARs/quality improvement plans
• Support quality agreement execution and tracking conformance to quality agreements
• Lead/facilitate risk management activities including planning, design & risk assessment
• Deliver Supplier Quality training, and host Supplier Quality status meetings
• Support internal audits
• Support Technology Transfer teams, and supplier transfer initiatives
• Maintain the ASL

About You:

We’re looking for a teammate with strong communication skills who thrives in a dynamic, collaborative environment. The ideal candidate is a quality professional with more than 5 years of experience in a GxP-regulated biopharmaceutical environment (cell and gene therapy) and at least 3 years of experience in Supplier Quality role. Other role requirements

• Bachelor’s or Master’s degree in Science, Engineering, or related discipline with +5 applied Quality industry experience
• Comprehensive knowledge and ability to audit to GMP and ICH regulations, ISO standards
• Experience negotiating Quality Agreements, SCARs/Quality improvement plans
• Strong understanding and background in quality principles and tools such as risk management, process controls, key performance indicators, statistical analysis etc.
• Experience implementing or managing supplier quality workflows – Veeva experience a plus
• Exceptional communication skills including writing, presentation, influencing, and conflict managementBachelor’s

Meet your future team:

You will report to the Associate Director of Supplier Quality and be a member of Technical Operations and Quality team. Our Supplier Quality team is growing to meet the challenges of maintaining/improving supply chain and streamlining the Supplier Quality program in readiness for commercial drug product supply. The Supplier Quality team is working remotely until COVID restrictions are lifted, and we will be adopting a flexible hybrid model after. While we build our team, we will be supported by a team of qualified consultants, including Lead auditors with GXP experience.

As a company, there is no road map for what we are doing as leaders in the systemic delivery of in vivo CRISPR-Cas9 therapies while offering a full spectrum approach to create CRISPR-Cas9 therapy via our ex vivo pipeline. We thrive on charting new territory, exploring new ways to drive our programs and the business forward, while promoting and cultivating the culture of ONE that has made, and continues to make, Intellia such an incredible place to work. It’s no wonder Intellia is placed #5 on BioSpace's Best Places to Work 2022, Top 30 Small Employers list.

We look forward to fostering your skills, strengthening our team through learning from your experiences, and working together as ONE to transform the lives of people with severe diseases by developing curative genome editing treatments.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

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.