Senior Manager, Quality Operations

Role: Senior Manager, Global Quality Operations, overseeing GMP quality for EyePoint's development and commercial manufacturing sites. Responsibilities: lead the Northbridge site quality team, manage batch record review, material release, QC testing, lot disposition, and regulatory compliance; develop and maintain quality systems aligned with cGMP and FDA standards; oversee documentation, audits, and inspections; collaborate with cross-functional teams including CMC, manufacturing, and supply chain; serve as quality lead on product development projects; mentor staff and support continuous improvement initiatives. Requirements: Bachelor's in a scientific or technical discipline; 10+ years in pharmaceutical or biotech industry with significant GMP and Quality Assurance Operations experience; proven leadership managing cross-functional teams, including CMO oversight; strong understanding of validation, inspection readiness, and electronic manufacturing systems (ERP/MES). Preferred: auditor certification, experience in combination device manufacturing, and regulatory inspection participation. HighValue: biologics or combination products, commercial and development phases, cGMP compliance, FDA regulation (21 CFR), and leadership in high-growth pharma/biotech environments. WorkSetup: hybrid in-person at Northbridge facility, with at least four days in-office.