Senior Quality Systems Lead – GMP & Compliance

Socket.dev; Cambridge (MA); On-site; USD 103,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) Match

HSA

Dental & Vision

Life & Disability Insurance

Tuition Reimbursement

Paid Time Off

Wellness Programs

Employee Assistance

Job summary

Editas Medicine is seeking a Senior Specialist, Quality Systems Management in Cambridge, MA to lead and optimize quality systems, ensure regulatory alignment, and support supplier audits. You will collaborate across functions to strengthen compliance, manage electronic documents, and drive process improvements.

The role requires a 5–8 year track record in Quality Systems within biopharma, experience with cGMP, and hands-on work with Veeva Quality apps and compliance tooling.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 5–8 years of Quality Systems/Quality Assurance experience in biopharma.
• Experience with cGMP environments and GMP documentation required.

Responsibilities

• Serve as SME for Quality Systems, ensuring compliance and continuous improvement.
• Maintain and optimize electronic document management (Veeva QualityDocs), QMS (Veeva QMS) and ComplianceWire.
• Lead risk-based supplier management: vendor qualification, performance monitoring, audits.

Skills

Quality Systems

Quality Assurance

Vendor Qualification

GMP Documentation

Veeva QualityDocs

Veeva QMS

ComplianceWire

FDA Regulations

GxP

Education

Bachelor’s degree in a scientific discipline

Tools

Veeva Quality

Regulatory Standards

Job description

Editas Medicine is seeking a Senior Specialist, Quality Systems Management in Cambridge, MA to lead and optimize quality systems, ensure regulatory alignment, and support supplier audits. You will collaborate across functions to strengthen compliance, manage electronic documents, and drive process improvements.

The role requires a 5–8 year track record in Quality Systems within biopharma, experience with cGMP, and hands-on work with Veeva Quality apps and compliance tooling.