Grifols · 1 day ago
Quality Manager
Texas, United States
Full-time
Onsite
Mid, Senior LevelGrifols is a global healthcare company dedicated to improving health and well-being since 1909. The Center Quality Manager will ensure compliance with quality standards and regulations, oversee quality control processes, and manage the quality team to enhance donor safety and product quality.
BiotechnologyHealth CareManufacturing
Responsibilities
Independent level of quality inspection and control -- ensures center compliance with quality standards and regulations
Collaborates with Center Managers to ensure product quality, donor suitability and donor safety
Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations
Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs
Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required
Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response
Also including implementation of corrective and preventative action, assessment of corrective and preventative actions and follow-up as required
Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents
Responsible for the personnel functions of the Quality Assoc(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all
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 the disposition of the associated results
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
Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports critical incidents and problematic trends to Center Manager
Reports compliance status to necessary parties
Ensures accuracy of donor files
Directs the maintenance and calibration of equipment and documentation of procedures
Ensures that Clinical Lab Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented
Monitors training documents to ensure compliance with all applicable policies and procedures
Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file
Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents
QM directs routine verification of the SOP and forms to ensure that they are up to date in the Donor Center’s manual
Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate
Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues
Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation
Qualification
Required
Bachelor of Science degree or equivalent
Certified and proficient in quality and compliance
Works toward certification from American Society for Quality to be a Certified Quality Auditor
Certification as a Designated Trainer for quality area is required
Company
Grifols
Grifols is a global healthcare company.
Founded in 1940
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