Quality Systems Manager
1 week ago
Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.
Key Responsibilities:- Maintain oversight of the center's quality management system and ensure continuous quality improvement by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
- Direct and monitor processes to ensure center compliance with all applicable state, federal, and company-designated regulations, and implement Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
- Maintain oversight of center training program by ensuring compliance to program requirements, promoting staff competency in their assigned job duties, and maintaining and auditing training records and files.
- Collaborate with Center Manager to ensure the donor center operates in a manner that assures product quality, donor suitability, and donor safety are maintained.
- Responsible for the personnel functions of the Quality 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.
- Continuously assess, promote, and improve the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations.
- Document, investigate, and perform root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
- Investigate identified trends and perform follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
- Oversee product and biohazard waste shipments, ensuring shipments meet regulatory specifications and product release requirements, accurate labeling and documentation, and authorization of final shipment.
- Perform a review of the documentation of unsuitable test results and unit lookback information.
- Perform a review of donor adverse event reports and the applicable related documentation.
- Ensure that job and center annual training (i.e., Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
- Perform employee training observations to ensure staff competency prior to releasing employees to work independently.
- Ensure that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiate appropriate investigations if these requirements are not met. Initiate rejection of supplies for non-conformance.
- Determine donor suitability activities and manage donor deferrals as appropriate. Review and approve deferred donor reinstatement activities.
- Prepare quality analysis reports to track issues and set goals. Conduct in-depth research and analysis to resolve systemic compliance issues.
- Ensure that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
- Hold monthly Quality Meeting to communicate status updates and manage action outcomes.
- 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.
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.
Occupational Demands:Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery, and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Ability to apply abstract principles to solve complex conceptual issues.
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