Quality Systems Manager for Plasma Center

Grifols•Portland, OR

14h•Onsite

About The Position

The Quality Systems Manager oversees the plasma donor center’s quality management system, evaluates processes, develops action plans, and coordinates implementation of system processes and corrective actions. The role ensures continuous quality improvement and compliance with applicable regulations while supporting product quality, donor suitability, and donor safety. It reports to the Regional Quality Manager and is based at the Portland, Oregon center. The manager oversees audits, investigations, corrective and preventive actions, training systems, supplies, donor suitability and deferrals, product and biohazard waste shipments, and quality documentation and reporting. The position also supervises the Quality Systems Associate and works with center leadership to address compliance issues, improve processes, and maintain staff competency.

Requirements

Bachelor of Science degree or equivalent.
Certified and proficient 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 level of computer proficiency.
Proficiency in root-cause analysis and corrective/preventive actions.
Ability to balance competing priorities and strong time-management abilities.
Proven ability to maintain quality and compliance 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, work independently, plan schedules to meet goals, interact with others, communicate sensitive information to diverse groups, build consensus, and apply abstract principles to complex issues.

Responsibilities

Maintain oversight of the center’s quality management system and address deficiencies in a timely manner, communicating concerns to appropriate parties.
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 work assignment, 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 identifying trends, investigating procedural failures, and conducting direct observations.
Document and investigate deviations and customer complaints, including 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, including regulatory and product-release requirements, labeling, documentation, and final shipment authorization.
Review documentation of unsuitable test results, unit lookback information, donor adverse event reports, and related documents.
Ensure required annual job and center training is completed, documented, and filed.
Observe employee training to verify staff competency before employees work independently.
Ensure supplies and materials meet quality requirements and are stored under appropriate temperature and facility conditions; investigate failures and reject noncompliant supplies.
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.