Quality Site Head

Role: Lead the Quality organization at the Norton manufacturing and testing facility, overseeing GMP Quality Assurance and Quality Control functions to ensure operational excellence, compliance, and inspection readiness for clinical and commercial production. Responsibilities: develop and execute site Quality strategy, manage investigations, deviations, CAPAs, change controls, and supplier quality; ensure timely testing and product release; lead quality systems design to meet global regulatory standards (FDA, EMA, ICH); support facility start-up, validation, and technology transfer; collaborate cross-functionally with manufacturing, engineering, regulatory, and development teams; foster a high-performance, compliant, and scalable quality culture. Requirements: Bachelor's in science or engineering; 15+ years of GMP quality leadership in pharma/biotech, with deep expertise in chemistry and Quality Control, preferably with experience in oligonucleotides, antibodies, or peptides; proven success in manufacturing, validation, validation, and regulatory interactions. Preferred: advanced degree; strong regulatory inspection history; experience leading both QA and QC organizations in a manufacturing environment. HighValue: senior leadership in GMP manufacturing, site start-up and commercialization, global regulatory compliance, and building quality systems supporting clinical and commercial biopharma operations at an on-site location in Norton, MA, with periodic travel.