Plasma Center Quality Systems Manager

GRIFOLS, S.A.•Hattiesburg, MS

10d•Onsite

About The Position

Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Quality Systems Manager (QSM) evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. This role 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. The QSM directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations, and implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. This role also maintains oversight of the center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties, and maintains and audits training records and files. The QSM collaborates with the Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained. This role is 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. The QSM is 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. The QSM continuously assesses, promotes, and improves 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. The QSM documents, investigates, and performs 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. The QSM investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. The QSM oversees product and biohazard waste shipments, ensuring shipments meet regulatory specifications and product release requirements, accurate labeling and documentation, and authorizes final shipment. The QSM performs a review of the documentation of unsuitable test results and unit lookback information, and reviews donor adverse event reports and the applicable related documentation. The QSM ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file. The QSM performs employee training observations to ensure staff competency prior to releasing employees to work independently. The QSM ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions, initiates appropriate investigations if these requirements are not met, and initiates rejection of supplies for non-conformance. The QSM determines donor suitability activities and manages donor deferrals as appropriate, and reviews and approves of deferred donor reinstatement activities. The QSM prepares quality analysis reports to track issues and set goals, and does in-depth research and analysis to resolve systemic compliance issues. The QSM ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented. The QSM holds monthly Quality Meetings to communicate status updates and manage action outcomes.

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.
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.

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.
Continuously assesses, promotes, and improves 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.
Documents, investigates, and performs 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.
Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation and authorizes final shipment.
Performs a review of the documentation of unsuitable test results and unit lookback information.
Performs a review of donor adverse event reports and the applicable related documentation.
Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities.
Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues
Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
Holds monthly Quality Meeting to communicate status updates and manage action outcomes.