Senior Quality Systems Lead – cGMP, Veeva & Compliance

Editas Medicine; Cambridge, Northern (MA, KY); Hybrid; USD 103,000 - 119,000; Full time

Benefits offered by this job

Blue Cross Blue Shield PPO

Health Savings Account

Tuition Reimbursement

401(k) plan with company match

Wellness Programs

Job summary

Editas Medicine is seeking a Senior Specialist, Quality Systems Management, to advance our lead in vivo program and strengthen QA processes. You will support electronic document management, QMS, and training systems, while coordinating supplier qualification and audit activities.

The role requires cGMP experience in biotech, cross-functional collaboration, and strong analytical and organizational skills. Join a team committed to improving patient outcomes through innovative gene-editing

Qualifications

• Experience implementing and maintaining Quality Systems in biotech/pharma.
• GMP documentation and regulatory alignment is required.
• Experience with vendor qualification and supplier audits is preferred.
• Bachelor's degree in a scientific field is required.

Responsibilities

• Serve as a subject matter expert for Quality Systems and drive improvement.
• Maintain and optimize EDRM and learning systems (Veeva/QMS/ComplianceWire).
• Lead risk-based supplier management, audits, and vendor qualification.
• Support audits, inspections, and CAPA activities as needed.

Skills

Quality Systems

Quality Assurance

Vendor Management

cGMP Compliance

GMP Documentation

ICH Q10 / FDA

Education

Bachelor's degree in a scientific discipline

Tools

Veeva Quality

Veeva QMS

ComplianceWire

Job description

Editas Medicine is seeking a Senior Specialist, Quality Systems Management, to advance our lead in vivo program and strengthen QA processes. You will support electronic document management, QMS, and training systems, while coordinating supplier qualification and audit activities.

The role requires cGMP experience in biotech, cross-functional collaboration, and strong analytical and organizational skills. Join a team committed to improving patient outcomes through innovative gene-editing