Grifols · 17 hours ago
Quality Manager for Plasma Center 1
Casa Grande, AZ
Full-time
Onsite
Mid, Senior Level
2+ years expGrifols is a global healthcare company that has been working to improve the health and well-being of people around the world. They are seeking a Quality Systems Manager to oversee the quality management system at the plasma donor center, ensuring compliance with regulations and continuous quality improvement.
BiotechnologyHealth CareManufacturing
Responsibilities
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
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 the 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 preventive 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 documents
Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as may be 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-compliance
Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves 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
Leads projects and initiatives as requested
Qualification
Required
Bachelor of Science degree or equivalent
Certified and proficient in quality and compliance
Typically requires 2-5 years of related experience in a medical and/or cGMP regulated environment
Experience with plasma or whole blood
Command of 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
Legible handwriting
High level of proficiency with computers
Proficient in root cause analysis and corrective/preventative actions
Ability to balance multiple competing priorities
Strong time management abilities
Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team
Ability to work with minimal supervision
Ability to travel when needed for meetings, events, and occasional support of other centers
Benefits
Full healthcare benefits
Tuition reimbursement
Some of our Academy courses even count for college credit
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase