Senior Specialist, Quality Systems Management

Editas Medicine

. Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement .

Posted 9/18/2026full-timeCambridge • Massachusetts • United StatesSenior💰 $103,000 - $119,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Systems and compliance within cGMP-regulated environments, with a strong focus on managing GMP documentation and supporting vendor management processes. Proven ability to collaborate cross-functionally while driving process improvements and maintaining inspection readiness.

Highest-signal resume keywords

Quality Management Systems AdministrationGMP Documentation ManagementVendor Qualification and ManagementRegulatory Compliance KnowledgeVeeva Quality Applications Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GMP DocumentationQuality SystemsRisk-Based Supplier ManagementProcess ImprovementQuality Event AssessmentAudit CoordinationRegulatory Standards KnowledgeAnalytical SkillsProblem-Solving SkillsCritical Thinking

Soft Skills

CollaborationOrganizational SkillsPrioritization SkillsIndependent Work

Tools & Technologies

Veeva QualityDocsVeeva QMSComplianceWireElectronic Document Management SystemsLearning Management Systems

Certifications & Qualifications

Auditor Training

Industry Keywords

CGMPBiopharmaceutical IndustryClinical DevelopmentGene TherapyBiologicsRNA TherapyCell TherapyViral Vector

About the role

Key responsibilities & impact

Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement
Support administration, maintenance, and optimization of Veeva QualityDocs, Veeva QMS, and 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
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
Identify process enhancements and contribute to initiatives that strengthen Quality Systems and compliance performance
Advance EDIT-401 into the clinic by maintaining, enhancing, and supporting phase-appropriate quality systems and vendor management processes

Requirements

What you’ll need

Strong experience administering and/or supporting electronic document management systems, Quality Management Systems, and learning management systems
Experience supporting vendor qualification, vendor management, and supplier auditing activities
Demonstrated expertise working within cGMP-regulated environments and managing GMP documentation
Working knowledge of ICH Q10, FDA regulations, applicable international regulatory standards, and regulatory expectations for clinical-stage biotechnology products, including gene therapy
Ability to work independently while collaborating effectively within a cross-functional, team-oriented environment
Strong analytical, problem-solving, and critical-thinking skills
Excellent organizational and prioritization skills with the ability to manage multiple activities simultaneously
Experience supporting biologics, protein, RNA, cell therapy, gene therapy, viral vector, and/or related products
Bachelor's degree in a scientific discipline with 5-8 years of Quality Systems, Quality Assurance, or related experience within the biopharmaceutical industry
Experience supporting Quality Systems within early-phase clinical development organizations
Hands-on experience with Veeva Quality applications
Auditor training and/or experience supporting supplier or internal audits
Experience supporting Quality Operations activities
Demonstrated ability to drive process improvements and support inspection readiness initiatives

Benefits

Comp & perks

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