Quality Systems Manager

3 days ago

Worcester, Massachusetts, United States Grifols Full time
About Grifols

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 over 110 countries and regions.

Job Summary

We are seeking a highly skilled Quality Systems Manager to join our team. The successful candidate will be responsible for maintaining oversight of the center's quality management system and ensuring continuous quality improvement. This will involve addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.

Key Responsibilities
  • Quality Management System Oversight: Maintain oversight of the center's quality management system and ensure continuous quality improvement.
  • Regulatory Compliance: Direct and monitor processes to ensure center compliance with all applicable state, federal, and company-designated regulations.
  • Training and Development: Maintain oversight of center training program and ensure compliance with program requirements.
  • Collaboration and Communication: Collaborate with Center Manager to ensure the donor center operates in a manner that assures product quality, donor suitability, and donor safety.
  • Personnel Management: Responsible for the personnel functions of the Quality Associate, including direction, assignment of work, hiring, development, and training.
  • Audit and Compliance: Responsible for oversight of all aspects of internal and external audits, including audit preparation, execution, response, and implementation of corrective/preventative actions.
  • Root Cause Analysis: Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center.
  • Documentation and Investigation: Documents, investigates, and performs root-cause analysis for deviations and customer complaints.
  • Product and Biohazard Waste Shipments: Oversees product and biohazard waste shipments to ensure they meet regulatory specifications and product release requirements.
  • Review of Unsuitable Test Results and Unit Lookback Information: Performs a review of the documentation of unsuitable test results and unit lookback information.
  • Review of Donor Adverse Event Reports: Performs a review of donor adverse event reports and the applicable related documentation.
  • Employee Training and Competency: Ensures that job and center annual training is completed, documented, and on file.
  • Supply Chain Management: Ensures that all supplies and materials ordered meet quality requirements prior to use.
  • Donor Suitability and Deferrals: Determines donor suitability activities and manages donor deferrals as appropriate.
  • Quality Analysis Reports: Prepares quality analysis reports to track issues and set goals.
  • CLIA Proficiency Test Surveys and Complaint Investigations: Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys and complaint investigations have been properly documented.
  • Quality Meetings: Holds monthly Quality Meeting to communicate status updates and manage action outcomes.
Requirements
  • Education: Bachelor of Science degree or equivalent.
  • Experience: Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood is preferred.
  • Knowledge, Skills, and Abilities: 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.
About Us

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic or status protected by law.

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