Quality Site Head

Role: Lead the Quality organization at the Norton Manufacturing and Testing Facility, serving as senior Quality leader responsible for GMP compliance, operational excellence, and inspection readiness for clinical and commercial products. Responsibilities: oversee Quality Assurance and Quality Control teams; drive strategic planning, quality systems development, and compliance with global regulations (FDA, EMA, ICH); manage investigations, deviations, CAPAs, validation, and supplier quality; support facility start-up, product release, and regulatory inspections; foster organizational capability through talent development and leadership. Requirements: Bachelor's in science or engineering; 15+ years GMP Quality leadership in pharma/biotech, with expertise in chemistry and quality control, preferably in oligonucleotide, antibody, or peptide modalities; proven success in GMP manufacturing, site start-up, and regulatory interactions. Preferred: experience leading site start-up, commercialization, and both QA/QC operations; strong regulatory inspection background. High-Value: GMP quality leadership, site start-up and commercialization, biologics or oligonucleotide focus, global regulatory compliance, on-site role in Norton MA, periodic travel to Cambridge and suppliers.