Head of Quality Control

Role: Head of Quality Control overseeing analytical chemistry, microbiology, and laboratory operations. Objectives: ensure compliance with industry standards, regulatory requirements, and drive quality excellence in laboratory performance. Responsibilities: lead 24/7 QC labs, manage teams, implement continuous improvement and digital innovation, oversee budgets, and ensure regulatory readiness, including inspections. Qualifications: bachelor's degree in science, engineering, or related field; 10+ years in QC or laboratory management, with 7+ in leadership; strong knowledge of cGMP, FDA, EMA, CFDA standards; experience in regulatory audits and contamination control preferred. HighValue: expertise in microbiology and analytical chemistry, large-scale multi-functional lab management, regulatory inspection management, and knowledge of endotoxin and sterility testing. WorkSetup: based in Lexington, MA; travel ~10%; requires work in controlled environments with PPE and shift flexibility.