Quality Systems Manager

Grifols•Greenville, SC

25d

About The Position

The Quality Systems Manager (QSM) oversees and improves the quality management and training systems at a plasma donor center. The role evaluates processes, develops action plans, coordinates quality system implementation, and ensures timely attention to deficiencies. It monitors regulatory compliance, implements quality control and compliance SOPs, and works with the Center Manager to maintain product quality, donor suitability, and donor safety. The QSM oversees internal and external audits, investigations, root-cause analyses, corrective and preventive actions, quality reporting, staff training, and related documentation. The role also oversees product and biohazard waste shipments, reviews donor test and adverse-event documentation, manages donor deferrals and reinstatements, and ensures supplies meet quality and storage requirements. The position supervises the Quality Systems Associate and holds monthly Quality Meetings. Work is performed in an office and/or laboratory/manufacturing environment, with exposure to biological fluids, infectious organisms, production chemicals, cold temperatures, machinery, and noise. Personal protective equipment is required. The role involves frequent sitting and driving to site locations, occasional walking and travel, and lifting or carrying objects up to 35 pounds. The position requires independent work, communication with diverse groups, and the ability to plan work to meet goals.

Requirements

Bachelor of Science degree or equivalent; directly related experience, education, and/or competencies may be considered as an equivalency depending on assignment.
Typically requires 2 years of related experience in a medical and/or cGMP-regulated environment.
Knowledge of FDA regulations and ability to assess regulatory requirements.
Strong interpersonal communication, organizational, and problem-solving abilities.
Strong integrity and commitment to quality and compliance.
Full command of mathematics and legible handwriting.
High proficiency with computers.
Proficiency in root-cause analysis and corrective and preventive actions.
Ability to balance competing priorities and manage time effectively.
Ability to maintain high quality and compliance standards and contribute to the center leadership team.
Ability to work with minimal supervision.
Ability to travel when needed for meetings, events, and occasional support of other centers.
Ability to communicate complex information, listen and understand spoken information, and work with diverse groups to obtain consensus.
Ability to work independently with little guidance, plan work schedules, and apply abstract principles to complex conceptual issues.
Ability to lift and carry objects weighing up to 35 pounds.
Ability to meet the role’s occupational demands, including frequent sitting, repetitive hand movements, occasional walking and bending, and required use of personal protective equipment.

Nice To Haves

Experience with plasma or whole blood.

Responsibilities

Evaluate processes, develop action plans, and coordinate strategic implementation of quality system processes and corrective actions at the plasma donor center.
Maintain oversight of the center’s quality management system and drive continuous quality improvement by addressing deficiencies and communicating concerns.
Direct and monitor processes to ensure compliance with applicable state, federal, and company regulations; implement SOPs for quality control and regulatory compliance.
Oversee the center training program, audit training records, and ensure staff competency in assigned duties.
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety.
Manage personnel functions for the Quality Systems Associate, including work direction, hiring, development, training, discipline, termination, records, scheduling, and task follow-up.
Oversee internal and external audits, including preparation, execution, responses, corrective and preventive actions, effectiveness assessments, and follow-up.
Assess and improve quality and training systems by identifying trends, investigating procedural failures, and conducting direct observations.
Document and investigate deviations and customer complaints, and perform root-cause analysis related to donor safety and product quality.
Investigate trends and follow up on corrective and preventive actions, system implementations, and process improvement plans to assess effectiveness.
Oversee product and biohazard waste shipments, ensuring regulatory and product-release requirements, accurate labeling and documentation, and authorization of final shipment.
Review documentation of unsuitable test results and unit lookback information.
Review donor adverse-event reports and related documentation.
Ensure required annual job and center training is completed, documented, and on file.
Observe employee training to verify competency before employees work independently.
Ensure supplies and materials meet quality requirements and are stored appropriately; initiate investigations or reject nonconforming supplies as needed.
Determine donor suitability activities, manage donor deferrals, and review and approve deferred donor reinstatement activities.
Prepare quality analysis reports, track issues, set goals, and research systemic compliance issues.
Ensure CLIA proficiency test surveys, complaint investigations, and training are properly documented.
Hold monthly Quality Meetings to communicate status updates and manage action outcomes.