<p>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.</p> <p>Job Overview:</p> <p>The Quality Manager will provide support to the Technical Director to ensure compliance of Quality Operations, Regulatory and cGMP Compliance Program of Grifols USA. Generates records to comply with regulatory requirements, (cGMP QSR/FDA/EN ISO Quality standards, Good Distribution Practices and Internal Quality Standard Operating Procedures) within the organization. The position ensures that the quality systems are in compliance with the rules and regulations of the regulatory agencies (FDA 21CFR, PIC/s GDP & EN ISO 9001) and that the company policies and procedures are being followed.</p> <p>Essential Job Duties:</p> <ul> <li>Manages the customers of the distributed medicinal products to ensure compliance to Good Distribution Practices. This includes qualification and requalification via risk analysis, desk audit or on-site audit. </li><li>Ensures the distributors of the medicinal products and medical devices have an established and current quality agreement. </li><li>Tracks the shipping complaints associated with the distribution of the products to ensure they are appropriately reported, recorded and resolved on a timely basis. </li><li>Creates and updates procedures to ensure they are well established and reflect current practices. </li><li></li></ul>