Sr. Manager, Quality Assurance for Quality Control

Role: Senior Manager, Quality Assurance for Quality Control at a biopharma company specializing in gene therapies, overseeing contract testing organizations for in-process and release testing of raw materials, starting materials, and drug products supporting commercial operations. Responsibilities: manage quality systems (deviations, investigations, CAPAs), lead stability program including data management and regulatory support, build relationships with CTOs/CMOs to ensure timely issue resolution, and support cGMP routine testing and documentation. Requirements: BS/MS in a scientific discipline, 5+ years in QC cGMP environments, experience managing CTOs/CMOs, stability program management, and familiarity with ICH, FDA, EMA regulations. High-Value: biologics/gene therapy modalities, commercial phase, cGMP compliance, stability testing, contract manufacturing interfaces, regulatory documentation, cross-functional collaboration. Work Setup: hybrid in Somerville, MA.