LIFELINE Blood Services
The Director of Quality and Regulatory Services plans, coordinates, directs, and evaluates the quality and compliance programs related to regulations, standards, and guidelines of licensing, accreditation, and certification agencies that govern blood center operations. The Director oversees the center-wide review and approval of Standard Operating Procedures. Responsible for maintaining all section Standard Operating Procedures (SOPs) to be in compliance with FDA regulations, AABB standards, and other regulatory guidelines pertinent to LIFELINE Blood Center operations. Keeps abreast of changes to quality regulations and guidelines. Guides efforts to reduce and prevent errors, improvements in the safety and quality of our manufacturing operations, and the protection of the health and safety of our donors and employees. Manages the overall deviation management program to include investigation, root cause analysis, corrective and preventative actions and documentation. Oversees and/or performs Quality Assurance audits to evaluate the effectiveness of the total quality system. Aids in the development and implementation of audit tools used by the department as well as the review and follow up of all corrective actions. Serves as an Authorized Official in pertinent matters with the Center for Biologics Evaluation and Research (CBER) and the FDA. Oversees and/or per-forms reviews and approvals of validation plans and results of validation activities. Coordinates and assists in maintaining safety and risk management functions that are performed by operational and administrative departments of the blood center. Interacts with hospitals and clients on Quality Assurance related issues. Develops and monitors department budget. Performs Donor counseling as needed. Bachelor’s degree or equivalent experience in medical technology or a clinical, allied health field. Please visit www.lifelinebloodserv.org to view the full job description and apply.