Quality Systems Manager, Plasma Donation Center

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.
• 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.
• 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.

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.
• 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.
• 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.