Quality Systems Manager for Plasma Center

Grifols
US - Montana - - - USA
June 25, 2024

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We're Grifols, an international plasma manufacturer headquartered in Barcelona, Spain. We serve healthcare professionals and patients in over 110 countries, have an unmatched record of product quality and safety, and are the largest plasmapheresis company in the world.

If you enjoy working in an environment built around teamwork and trust, then consider furthering your career with us as a QUALITY SYSTEMS MANAGER! Please read on .

Job Title: QUALITY SYSTEMS MANAGER

Summary:

Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions.

Primary Responsibilities for Role:

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 includes 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 Systems Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule and delegation/follow-up of tasks.
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.
Works in collaboration with the Center Manager to develop the staff's knowledge of their job function and how their performance relates to the end product and patient.
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.

Other Responsibilities for Role:

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.

Read the full job description and apply online on the recuiter's web-site

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