Senior Manager, Quality Operations

Role: Senior Manager of Quality Operations overseeing global GMP quality for development and commercial manufacturing at the Northbridge site. Responsibilities: build and lead the quality operations team, manage incoming material release, batch review, QC testing, lot disposition, and oversee compliance with cGMP, FDA regulations (21 CFR parts 11, 820, 210, 211). Collaborate with cross-functional teams including Quality, Manufacturing, and external CMOs; develop quality systems, policies, and procedures; review and approve GMP documents; participate in inspections; train staff; and serve as Quality Lead on product development teams. Requirements: Bachelor’s degree in a scientific or technical discipline; 10+ years in pharmaceutical or biotech industry, with proven leadership in Quality Assurance operations, manufacturing compliance, and FDA-regulated environments. Skills: GMP expertise, experience with validation, electronic manufacturing systems (ERP/MES preferred), audit/certification, and managing CMO operations. Experience in combination products and in a high-growth, fast-paced environment is desirable. High-Value: oversight of manufacturing quality at a critical site, leadership in GMP compliance, experience with inspection readiness, and cross-functional collaboration in drug development and commercialization. WorkSetup: in-person at Northbridge with hybrid schedule, requiring at least three days in the office, with some flexibility.