Senior Specialist, Quality Systems Management

Role: Senior Specialist, Quality Systems Management, supporting the clinical development of Editas Medicine's in vivo gene editing candidate, EDIT-401, aimed at reducing LDL cholesterol. Responsibilities: manage and optimize quality systems (Veeva QMS, QualityDocs, ComplianceWire), support vendor qualification and audits, author GMP documentation, collaborate cross-functionally on quality and compliance processes, and support audit/inspection activities. Requirements: Bachelor's in a scientific field, 5-8 years in Quality Assurance within biopharma, experience with electronic quality systems, vendor management, and cGMP environments, with knowledge of ICH Q10, FDA, and international standards. Preferred: experience with biologics, gene therapy, cell therapy, viral vectors, and early-phase clinical development. High-Value: clinical-stage biotechnology focus, gene therapy modality, GMP compliance, vendor management, and support of regulatory activities in a collaborative, innovative setting. WorkSetup: not specified; salary range $103K-$119K.