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# Specialist, Quality Systems Management

- **Company:** Editas Medicine
- **Location:** United States
- **Experience:** Expert
- **Salary:** $103,000.0 - $119,000.0
- **Contract:** Permanent contract
- **Skills:** Learning Management Systems, Document Management Systems, Performance Monitor, Veeva
- **Published:** September 18, 2026
- **Apply:** https://www.thejobnetwork.com/job/ad794c92-26bb-438e-8192-df7cdcd3831f/senior-specialist-quality-systems-management

## About the Role

* 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.

Fundamentals That Set You Apart

 * 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.

## Description

* 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.


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