Quality Systems Manager for Plasma Center

GRIFOLS, S.A.•Modesto, CA

2d•$68,640 - $102,960•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 drives continuous improvement while ensuring compliance with applicable regulations and company requirements. It reports to the Regional Quality Manager. The manager collaborates with the Center Manager to support product quality, donor suitability, and donor safety; leads personnel functions for the Quality Systems Associate; and oversees internal and external audits, investigations, training, corrective and preventive actions, and process improvements. The position also oversees regulated product and biohazard waste shipments, reviews donor testing and adverse-event documentation, manages donor suitability and deferrals, verifies the quality and storage of supplies, and prepares quality analyses and reports. The role holds monthly quality meetings and may lead projects and initiatives as requested. Work is performed in an office and/or laboratory/manufacturing environment at a plasma center. The role may involve exposure to biological fluids, infectious organisms, chemicals, extreme cold, moving machinery, and high noise levels. Personal protective equipment is required. The position requires frequent sitting and driving to site locations, occasional walking and travel, and light-to-moderate lifting up to 35 pounds. The role involves working independently, communicating complex and sensitive information, and coordinating with diverse groups.

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.
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 strong time-management abilities.
Ability to maintain high quality and compliance standards and contribute to the center leadership team.
Ability to work with minimal supervision.
Ability to travel as needed for meetings, events, and occasional support of other centers.
Ability to communicate complex information, listen and understand spoken information, work independently, plan work schedules, interact with others, communicate sensitive information to diverse groups, build consensus, and apply abstract principles to complex conceptual issues.
Ability to meet the occupational demands, including light-to-moderate lifting and carrying up to 35 pounds and use of required personal protective equipment.

Responsibilities

Maintain oversight of the center’s quality management system, address deficiencies promptly, and communicate concerns to appropriate parties.
Direct and monitor processes to ensure center compliance with applicable state, federal, and company-designated regulations; implement quality-control and regulatory-compliance SOPs.
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, assignments, hiring, development, training, discipline, termination, personnel records, work 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 the effectiveness of quality and training systems by identifying trends, investigating procedural failures, and conducting direct observations.
Document and investigate deviations and customer complaints, perform root-cause analysis, and assess donor safety and product quality implications.
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, including regulatory and release requirements, labeling, documentation, and final shipment authorization.
Review documentation for unsuitable test results and unit lookback information.
Review donor adverse-event reports and related documents.
Ensure required annual job and center training is completed, documented, and on file.
Conduct employee training observations to verify staff competency before employees work independently.
Verify that ordered 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, track issues, set goals, and research and analyze 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.