Manager, Quality Systems

Manager, Quality Systems

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas
12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

At Editas Medicine, we're a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what's possible in medicine, come join us and become an Editor!

The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic to establish human proof of concept by maintaining and improving our phase-appropriate quality systems and vendor management program. This role is part of a small QA team with opportunities for cross training into other areas of Quality. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels.

The company is very excited by the potential of this experimental treatment which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.

As the Manager, Quality Systems, you will:

• Oversee Quality Systems ensuring health, effectiveness, and compliance.
• Support the management and administration of the electronic document management system (Veeva Quality Docs), the electronic quality management system (Veeva QMS), and the electronic learning management system (Compliance Wire).
• Oversee risk-based supplier management program including vendor qualification, monitoring and audit management.
• Author, review and approve GMP documentation (SOPs, work instructions, training) associated with Quality Systems.
• Establish, implement, maintain, improve, monitor and report on quality and compliance systems.
• Assist in Quality Operations activities including record reviews, disposition activities, and Quality Event reviews.