Quality Systems Manager

Responsibilities Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. Maintains oversight of the center’s quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties. Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files. Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained. Responsible for the personnel functions of the Quality Systems Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks. Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required. Requirements Bachelor of Science degree or equivalent. Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood preferred. Command of interpersonal communication, organizational and problem-solving abilities. Ability to understand and assess FDA regulations. Strong integrity and commitment to quality and compliance. Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. Ability to balance multiple competing priorities. Strong time management abilities. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision.Ability to travel when needed for meetings, events, and occasional support of other centers. #J-18808-Ljbffr