Center Quality Manager

Role: Center Quality Manager responsible for ensuring compliance with GMP, federal, state, and international regulations at ADMA Biologics' donor centers. Objectives include developing policies and procedures, maintaining audit readiness, and overseeing product release and labeling. Responsibilities: manage daily quality assurance activities, lead staff training, track errors and corrective actions, and report on compliance metrics. Qualifications: Bachelor's degree or equivalent; extensive experience in GMP environments, ideally within biologics or plasma products; proficiency in Oracle, SQL, Jaspersoft, and regulatory standards such as 21 CFR Parts 210-211, 600, 610, 820, ICH, and IQPP. Skills include excellent communication, organizational, and analytical abilities, with knowledge of sterilization, facility maintenance, and cGMP compliance. Experience with process development, scaling bioprocesses, and data analysis is preferred. High-value specifics include expertise in immunoglobulin biochemistry, protein purification, and process validation within blood plasma or biologics manufacturing, with a focus on regulatory and quality oversight. The role involves collaboration with operations management and adherence to regulatory and SOP standards. Work setup: primarily on-site in Hammond, LA, with physical requirements including extended standing, lifting, bending, and potential exposure to bloodborne pathogens.