Manager, Quality Systems

About the Company

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.

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.

About 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 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, which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.

Responsibilities

• Oversee Quality Systems ensuring health, effectiveness, and compliance.
• Support the management and administration of the electronic document management system (Veeva QualityDocs), the electronic quality management system (Veeva QMS), and the electronic learning management system (ComplianceWire).
• 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.

Requirements

• Expertise managing and/or administering electronic document systems, Quality Management Systems, and learning management.
• Experience with vendor management, onboarding, and auditing.
• Expertise working within cGMP compliance and providing GMP documentation.
• Working knowledge of ICH Q10, FDA CFRs, and other applicable international regulatory standards for clinical trial material in global markets, including understanding of regulatory guidance on gene therapy products.
• Proven ability to work independently as well as to collaborate with peers and work effectively in a team-oriented environment.
• Strong problem-solving and critical-thinking ability.
• Highly organized and self-directed with ability to prioritize workload and escalate appropriately.
• Experience with biologics, protein, RNA, cell, gene therapy, and/or viral products.
• B.S. in a scientific discipline with 6+ years of experience within Quality and other relevant roles in the biopharmaceutical industry.

Qualifications

• Experience supporting early phase Quality.
• Experience with Veeva.
• Experience as an auditor.
• Experience with QA Operations.

Benefits

• Blue Cross Blue Shield PPO Medical Plan
• Company-funded Health Savings Account
• Dental and Vision Insurance
• Life and Disability Insurance
• Dependent Care Account
• Tuition Reimbursement
• 401(k) plan with company match
• Employee Assistance Plan
• Wellness Programs
• Flexible Paid Time Off policy

Pay

Salary Range: $135,000 - $150,000

The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered.