Jobs at Editas Medicine

Editas Medicine is a biotechnology company focused on CRISPR/Cas9 and CRISPR/Cas12a gene-editing technologies. Its goal is to develop precision genomic medicines for serious diseases. The role specifically supports EDIT-401, an experimental one-time therapy being developed to significantly reduce LDL cholesterol.The Manager, Quality Systems is responsible for maintaining and improving the company's quality systems, GMP compliance, electronic quality platforms, and supplier/vendor management. The position supports the advancement of EDIT-401 into clinical development and works within a small QA team.

• Manage and maintain quality management systems to ensure they remain effective, compliant, and up to date.
• Support the administration and daily operation of Veeva QualityDocs, Veeva QMS, and ComplianceWire platforms.
• Manage supplier and vendor qualification processes, including onboarding, performance monitoring, and audits.
• Prepare, review, and approve GMP-related documents such as SOPs, work instructions, and training materials.
• Monitor quality and compliance activities and identify opportunities for improving existing processes.
• Maintain appropriate quality records and support documentation control activities.
• Assist with quality operations, including record review, product disposition, and investigation of quality events.
• Ensure quality processes comply with applicable GMP, FDA, ICH, and international regulatory requirements.
• Support quality activities related to clinical-stage gene therapy and other biopharmaceutical products.
• Work closely with cross-functional teams to resolve quality issues and support business and development objectives.
• Identify potential compliance risks and take appropriate actions to prevent or address them.
• Contribute to continuous improvement initiatives within the Quality organization.

• Bachelor’s degree in a scientific discipline or a related field.
• 6+ years of experience in Quality Assurance, Quality Systems, or related roles within the biopharmaceutical industry.
• Experience managing electronic Quality Management Systems (QMS), document management systems, and learning management systems.
• Hands-on experience with Veeva QualityDocs, Veeva QMS, or similar quality platforms.
• Experience in supplier and vendor qualification, monitoring, onboarding, and auditing.
• Strong knowledge of cGMP requirements and GMP documentation practices.
• Working knowledge of ICH Q10, FDA CFRs, and applicable international regulatory standards.
• Understanding of quality and regulatory requirements for gene therapy and other advanced biopharmaceutical products.
• Experience working with biologics, proteins, RNA, cell therapy, gene therapy, or viral products.
• Knowledge of Quality Assurance and Quality Operations processes.
• Strong documentation and record-management skills.
• Strong analytical and problem-solving abilities.
• Excellent organizational and time-management skills with the ability to prioritize multiple tasks.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Strong communication and stakeholder-management skills.
• Experience supporting audits, inspections, quality events, and continuous improvement activities.