Head of Pharmaceutical Quality Assurance

3 weeks ago

Edinburg, Texas, United States Grifols Full time
Quality Assurance Manager

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in more than 110 countries and regions.

Job Summary

We are seeking a Quality Assurance Manager to join our team in Edinburg, TX. The successful candidate will be responsible for ensuring the quality and compliance of our products and processes, and will work closely with our Center Managers to ensure that our facilities meet the highest standards of quality and safety.

Key Responsibilities
  • Ensure compliance with all applicable state, federal, and company-designated regulations and standards.
  • Collaborate with Center Managers to ensure product quality, donor suitability, and donor safety.
  • Direct and monitor processes to ensure center compliance with all applicable regulations and standards.
  • Ensure that Standard Operating Procedures (SOPs) are properly interpreted, implemented, and followed by staff.
  • Interpret and implement processes, regulations, and SOPs for quality control and overall regulatory compliance.
  • Oversee all aspects of internal and external audits, including execution, documentation, review, and preparation of responses.
  • Implement corrective and preventative actions, assess their effectiveness, and follow up as required.
  • Continuously assess, promote, and improve the effectiveness of the quality systems in the donor center.
  • Responsible for the personnel functions of the Quality Associates, including direction, assignment of work, hiring, development, and training.
  • Oversee product and biohazard waste shipments to ensure compliance with regulatory specifications and product release requirements.
  • Perform a review of the documentation of unsuitable test results and the disposition of the associated results.
  • Document, investigate, and perform root cause analysis for deviations and customer complaints.
  • Document and track/trend center quality incidents and follow up as required.
  • Report compliance status to necessary parties.
  • Ensure accuracy of donor files.
  • Direct the maintenance and calibration of equipment and documentation of procedures.
  • Ensure that Clinical Lab Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
  • Monitor training documents to ensure compliance with all applicable policies and procedures.
  • Ensure that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file.
  • Ensure 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.
Requirements
  • 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.
Location

Edinburg, TX

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