Quality Systems Manager

3 days ago

Worcester, Massachusetts, United States Grifols Full time
Quality Systems Manager Job Description

Grifols is seeking a highly skilled Quality Systems Manager to join our team. As a key member of our organization, you will be responsible for maintaining oversight of the center's quality management system and ensuring continuous quality improvement.

Key Responsibilities:
  • Maintain oversight of the center's quality management system and ensure continuous quality improvement.
  • Direct and monitor processes to ensure center compliance with all applicable state, federal, and company-designated regulations.
  • Implement Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
  • Maintain oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties.
  • Collaborate 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 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 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 preventative 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 documentation.
Requirements:
  • Bachelor of Science degree or equivalent.
  • Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood.
  • Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.
What We Offer:
  • Medical, PTO, up to 5% 401K match, and tuition reimbursement.
  • Opportunities for professional growth and career progression.
  • A family-like culture with a commitment to quality and compliance.

Grifols is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive environment that values diversity and promotes equal opportunities for all employees and applicants.

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