Senior Specialist, Quality Systems Management

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a 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.

Why Choose Editas?

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!

Decoding The Role:

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 by maintaining, enhancing, and supporting phase-appropriate quality systems and vendor management processes. This role is part of a collaborative QA team, offering opportunities to broaden expertise across multiple Quality disciplines. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is 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.

Characterizing Your Impact:

As the Senior Specialist, Quality Systems Management, you will:

• Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement.
• Support the administration, maintenance, and optimization of the electronic document management system (Veeva QualityDocs), electronic quality management system (Veeva QMS), and learning management system (ComplianceWire).
• Execute and support risk-based supplier management activities, including vendor qualification, performance monitoring, and audit coordination.
• Author, review, and manage GMP documentation, including SOPs, work instructions, and training materials associated with Quality Systems.
• Partner cross-functionally to implement, maintain, improve, monitor, and report on quality and compliance processes.
• Support Quality Operations activities, including record reviews, disposition support, and Quality Event assessments.
• Assist with internal and external audits, inspections, and follow-up activities as needed.
• Identify opportunities for process enhancements and contribute to initiatives that strengthen Quality Systems and compliance performance.