Quality Systems Manager for Plasma Center

Overview

Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company with a long history of enhancing health and well-being. We are a leading plasma-derived medicines and transfusion medicine company operating in more than 110 countries and regions. We offer full healthcare benefits, tuition reimbursement, and some Academy courses that count for college credit.

If you enjoy teamwork and trust-based work culture, consider advancing your career with us as a QUALITY SYSTEMS MANAGER
!

Final date to receive applications: February 20, 2025

Job Title: QUALITY SYSTEMS MANAGER

Estimated Salary Range: $68,640.00 - $ per year, depending on training, education, and experience. This position is eligible to participate in up to 20% of the company bonus pool.

Relocation Assistance: This position is eligible for relocation assistance of up to $20K.

Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions at the plasma donor center. Reports to the Regional Quality Manager.

• Maintains oversight of the center’s quality management system and ensures continuous quality improvement, 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.
• Collaborates with Center Manager to ensure the donor center operates in a manner which ensures product quality, donor suitability and donor safety are maintained.
• Oversees 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.
• Oversees internal and external audits including audit preparation, execution, response, corrective/preventive actions, assessment of actions, and follow-up as required.
• Continuously assesses, promotes, and improves the effectiveness of the quality and training systems in the donor center through trend recognition, investigation of failures, and direct observations.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints related to donor safety and product quality.
• Investigates identified trends and follows up on corrective and preventive actions, system implementations, and process improvement plans to measure effectiveness.
• Oversees product and biohazard waste shipments: ensures regulatory specifications and product release requirements are met; ensures accurate labeling and documentation; and authorizes final shipment.
• Reviews documentation of unsuitable test results and unit lookback information.
• Reviews donor adverse event reports and related documentation.
• Ensures annual job and center training (e.g., Advanced cGMP, Blood Borne Pathogen, and other required trainings) is completed, documented, and on file.
• Performs employee training observations to ensure staff competency prior to independent work.
• Ensures supplies and materials meet quality requirements, stored under proper conditions, and initiates investigations or rejects non-compliant items.
• Determines donor suitability activities and manages donor deferrals; reviews and approves deferred donor reinstatement.
• Prepares quality analysis reports to track issues and set goals; conducts in-depth research to resolve systemic compliance issues.
• Ensures CLIA proficiency surveys, complaint investigations, and training are properly documented.
• Holds monthly Quality Meeting to communicate status updates and manage action outcomes.

• Leads projects and initiatives as requested.

Education:

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.

Experience:

• Typically requires 2-5 years of related experience in a medical and/or cGMP regulated environment.
• Experience with plasma…