Donor Station (Bio Sourcing) Manager

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.

Grifols Diagnostic Solutions is seeking a Donor Station (Bio Sourcing) Manager to oversee our Immunohematology Blood Typing Solutions Manufacturing. The Donor Station (Bio Sourcing) Manager will establish the necessary strategy to ensure the critical raw materials sourcing for IH reagents manufacturing. This role will drive the execution of that strategy to allow having these raw materials on time, in compliance with the quality specifications as well as with the appropriate cost. The Donor Station (Bio Sourcing) Manager will have an end-to-end responsibility, from the sourcing until the final usage in the labs.

To be successful in this role, we are seeking candidates to have at least a bachelor’s in biology, or similar related with 8 years of Immunohematology and Blood Bank experience.

Responsibilities

• Procures all biological materials, human blood, and blood components (QC plasmas, whole blood samples, RBC bags for production, validations, other studies, etc.) according to product specifications
• Participates in the development and redesign of product requirements and processes related to Reagent Red Blood Cells, in collaboration with other Grifols manufacturing sites
• Maintains strategic view of bio-suppliers around the country and/or outside US to allow the current and future raw materials supply
• Creates, maintains and expands a supplier portfolio across the country. Main contact with all bio-suppliers, both operational and technical aspects
• Coordinate the supplier’s qualifications (information gathering, technical visits, audits, etc.
• Monitor and follow up the supplier’s performance     
• Negotiates all supply agreements to enable the manufacturing plant to meet timeline, frequency and cost.
• Negotiates all quality agreements to enable the manufacturing plant having the correct internal and external technical development for all bio raw materials for IH
• Coordinates and collaborates with GLS lab for all RBC typing activities
• Assists Grifols companies and potential customers in the preparation of reagent red blood cells.
• Responsible for the fresh and frozen blood bags inventory. Maintain adequate frozen and fresh panel supply for back-up and emergency use.
• Combines the frozen bags in stock to prepare the different RRBC panels, in collaboration with the Planning Department to plan the different RRBC's campaigns.
• Participates in the improvement and validation of the DPM (DPSE) tool, used to create the panels.
• Gives technical support to Manufacturing and QC departments during the RRBC's manufacturing campaigns.
• Maintains US supplier FDA / ISO certification licenses list up to date
• Attends annual blood transfusion related meetings or conferences with suppliers   
• Writes and maintains the SOP's needed to develop the different tasks (Donor Station, DPM, GLS, etc.).
• Coordinates all complaints, CAPA's, quality notifications involving the suppliers.
• Participates and gives assistance in FDA or other regulatory entity inspections
• Internal training of IH which defines the strategy of all new employees working in blood typing solutions plant
• Support Training Development in the development of training materials for the department.
• Some travel may be required
• Leads tours