Quality Systems Manager

Role Summary

Quality Systems Manager (QSM) at Grifols, Charlotte, NC. Responsible for leading quality system processes at the plasma donor center, ensuring product quality, donor safety, and regulatory compliance, and driving continuous improvement, audits, investigations, and training initiatives.

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.

Qualifications

• Bachelor of Science degree or equivalent.
• Equivalency: Depending on area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master’s degree with 2 years of experience.
• Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood preferred.

Skills

• 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 and high level of proficiency with computers.
• Proficient in root cause analysis and corrective/preventative actions (CAPA).
• Ability to balance multiple competing priorities and strong time management abilities.
• Proven ability to maintain a high level of quality and compliance and to contribute as a valuable member of the center leadership team; ability to work with minimal supervision; ability to travel for meetings and occasional support of other centers.

Additional Requirements

• Occupational demands: Work is performed in an office and/or a laboratory/manufacturing environment with exposure to biological fluids and potential exposure to infectious organisms; exposure to electrical office equipment; exposure to extreme cold below 32 degrees F, production chemicals, moving machinery and production equipment; high noise levels in production areas; personal protective equipment required (protective eyewear, garments and gloves).
• Physical demands: Frequently sits for 6-8 hours per day; repetitive hand movements; occasionally walks; occasionally bends and twists neck; light to moderate lifting and carrying objects up to 35 lbs.
• Travel: Frequently drives to site locations with occasional travel within the United States; ability to travel when needed for meetings and occasional support of other centers.
• Works independently with little guidance, plans work schedules to meet goals, and interacts with diverse groups to obtain consensus on issues.