Director Quality Assurance, Drug Substance Manufacturing

Role: Director of Quality Assurance leading QA functions for a greenfield biologics Drug Substance manufacturing facility in Saratoga Springs, NY. Primary objectives include establishing QA systems, building an automation and data integrity framework, and ensuring compliance during facility startup and long-term operations. Responsibilities encompass developing quality processes aligned with FDA and international standards, overseeing automation systems (MES, DCS/SCADA, LIMS), and implementing review-by-exception batch disposition models. The role involves leading cross-functional teams, managing quality during commissioning, qualification, validation, and routine production, and serving as the company’s face during regulatory audits. Qualifications: Bachelor’s in Life Sciences, Engineering, or related field; 12+ years in cGMP biologics/QMS roles, with 4+ years in leadership. Experience with facility startup, automation, data integrity, and biologics operations (cell culture, chromatography, aseptic processing) highly preferred. High-value specifics include biologics/Drug Substance manufacturing, greenfield facility commissioning, automation systems, and regulatory compliance in an innovative, highly automated environment. The role reports to senior management, involves strategic planning, team leadership, and collaboration with automation, engineering, and IT functions. Work setup is onsite in Saratoga Springs, NY, with no travel specified.