Quality Systems Manager for Plasma Center

Grifols•Aurora, CO

20h•Onsite

About The Position

The Quality Systems Manager evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions at a plasma donor center. The role maintains oversight of the center’s quality management system and supports continuous quality improvement, regulatory compliance, product quality, donor suitability, and donor safety. The position reports to the Regional Quality Manager and works with the Center Manager and center leadership. The manager oversees audits, investigations, corrective and preventive actions, training, donor suitability activities, supplies, product and biohazard waste shipments, and quality documentation. The role also supervises the Quality Systems Associate and prepares quality analysis reports, conducts research into systemic compliance issues, and leads monthly quality meetings. Work takes place in an office and/or laboratory or manufacturing environment, with travel to sites and occasional travel within the United States.

Requirements

Bachelor of Science degree or equivalent.
Certification and proficiency in quality and compliance.
Typically 2–5 years of related experience in a medical and/or cGMP-regulated environment.
Experience with plasma or whole blood.
Strong 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 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.
Demonstrated ability to maintain high quality and compliance standards and contribute to a 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 to and understand spoken information, work independently, and plan work schedules to meet goals.
Ability to interact with others, communicate sensitive information to diverse groups, build consensus, and apply abstract principles to complex conceptual issues.
Ability to meet the described physical and occupational demands, including frequent sitting, repetitive hand movements, occasional walking and bending, and lifting and carrying up to 35 pounds.

Responsibilities

Maintain oversight of the center’s quality management system, address deficiencies promptly, communicate concerns, and drive continuous quality improvement.
Direct and monitor processes to ensure compliance with applicable state, federal, and company-designated regulations.
Implement Standard Operating Procedures for quality control and regulatory compliance.
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety.
Manage personnel functions for the Quality Systems Associate, including assigning work, hiring, development, training, discipline, termination, personnel records, scheduling, and task follow-up.
Oversee internal and external audits, including preparation, execution, responses, corrective and preventive actions, assessment, and follow-up.
Assess and improve quality and training systems by recognizing trends, investigating procedural failures, and conducting direct observations.
Document and investigate deviations and customer complaints, perform root-cause analysis, and assess their relationship to donor safety and product quality.
Investigate trends and follow up on corrective and preventive actions, system implementations, and process improvement plans to determine effectiveness.
Oversee product and biohazard waste shipments, verify regulatory specifications, product release requirements, labeling and documentation, and authorize final shipment.
Review documentation of unsuitable test results and unit lookback information, as well as donor adverse event reports and related documents.
Ensure required annual job and center training is completed, documented, and on file; observe employee training and verify competency before employees work independently.
Ensure supplies and materials meet quality requirements and are stored under appropriate temperature and facility conditions; initiate investigations or reject noncompliant supplies as appropriate.
Determine donor suitability activities, manage donor deferrals, and review and approve deferred donor reinstatement activities.
Prepare quality analysis reports to track issues and set goals, and conduct in-depth research and analysis to resolve 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.
Lead projects and initiatives as requested.
Travel when needed for meetings, events, and occasional support of other centers.