Quality Manager

GRIFOLS, S.A.•Stonecrest, GA

25d

About The Position

The Center Quality Manager oversees quality inspection, control, and regulatory compliance at a donor center. The role works with Center Managers to support product quality, donor suitability, and donor safety, and ensures staff follow applicable standard operating procedures (SOPs), regulations, and company requirements. The manager evaluates and improves center quality systems, oversees audits and corrective and preventive actions, and investigates deviations, complaints, incidents, and compliance trends. The role also leads personnel functions for Quality Associates; oversees product and biohazard waste shipments; reviews unsuitable test results and related dispositions; ensures accurate donor files and training documentation; and oversees equipment maintenance and calibration. The manager monitors quality control checks, SOP and form currency, CLIA proficiency testing documentation, and cGMP training. In partnership with the Center Manager, the role supports donor suitability and deferrals, prepares quality analysis reports, researches systemic compliance issues, and builds rapport with donors to support customer satisfaction and long-term donation.

Requirements

Bachelor of Science degree or equivalent.
Certified and proficient in quality and compliance.
Certification as a Designated Trainer for the quality area is required.

Nice To Haves

Works toward certification from the American Society for Quality as a Certified Quality Auditor.

Responsibilities

Ensure the center complies with quality standards, applicable regulations, and company requirements through independent quality inspection and control.
Collaborate with Center Managers to ensure product quality, donor suitability, and donor safety.
Direct and monitor processes to ensure compliance with state, federal, and company-designated regulations.
Ensure SOPs are properly interpreted and timely implemented, and that staff perform according to them.
Interpret and implement quality-control and regulatory processes, regulations, and SOPs, making independent decisions and modifications as required.
Oversee internal and external audits, including execution when applicable, documentation, review, preparation of responses, and corrective and preventive actions and follow-up.
Assess, promote, and improve the effectiveness of donor-center quality systems by reviewing trends, investigating procedural failures, observing employees, and reviewing center documents.
Direct Quality Associate personnel functions, including assigning and directing work, hiring, development, training, discipline, and termination.
Oversee product and biohazard waste shipments, ensuring regulatory specifications, product-release requirements, accurate labeling and documentation, and final shipment authorization.
Review documentation of unsuitable test results and disposition of associated results.
Document and investigate deviations and customer complaints, and perform root cause analysis related to donor safety and product quality.
Document, track, and trend center quality incidents; follow up as required and report critical incidents and problematic trends to the Center Manager.
Report compliance status to necessary parties.
Ensure donor files are accurate.
Direct equipment maintenance and calibration and documentation of procedures.
Ensure CLIA proficiency test surveys, complaint investigations, and training are properly documented.
Monitor training documents for compliance with applicable policies and procedures.
Ensure job and cGMP training is completed, documented, and on file.
Ensure required quality control checks are performed and test reagent results are within acceptable ranges.
Direct routine verification of SOPs and forms to ensure they are current in the Donor Center manual.
Partner with the Center Manager to determine donor suitability activities and manage donor deferrals as appropriate.
Prepare quality analysis reports to track issues and set goals, and conduct in-depth research and analysis to resolve systemic compliance issues.
Build rapport with donors to support customer satisfaction and long-term donation.