Director, Bio Supplies Medical Department

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.

Summary:

Reporting to the Corporate Medical Director, the Director, Bio Supplies Medical Department provides medical oversight and guidance for a group source plasma, whole blood, blood component, and specialty plasma collection centers and their corresponding medical directors, laboratory directors, and center medical staff. The human-derived blood, plasma, and materials collected at these centers are used in pharmaceutical and diagnostic manufacturing, as well as in life science research. The Director may also serve as a center medical and / or laboratory director for a Bio Supplies collection center(s) with all the responsibilities pertaining to those positions.

Primary Responsibilities:

• Be readily familiar with Current Good Manufacturing Practices (cGMP), applicable State and Federal guidelines, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics Association (PPTA) Standards Program, AABB Standards for Blood Banks and Transfusion Services, pertinent sections of the Code of Federal Regulations (CFR) and pertinent sections of the European Regulations including but not limited to the European Blood Directives, European Directorate for The Quality of Medicines and Health Care (EDQM), European Pharmacopoeia and The Pharmaceutical Inspection Co-operation Scheme (PIC/S).
• Be readily familiar with the approved Standard Operating Procedures (SOP) for the Bio Supplies whole blood, blood component, and specialty plasma collection centers and maintain certification as a center medical and laboratory director with all the job responsibilities and corresponding medical licensures pertaining to those positions.
• Serve as a member of the Bio Supplies Business Unit Leadership Team.
• Provide medical oversight, guidance, and subject matter expertise to the Bio Supplies whole blood, blood component, and specialty plasma collection centers.
• Manage and supervise any other medical support staff for the Bio Supplies Medical Department as assigned.
• Conduct as needed meetings with center medical and laboratory directors.
• Lead the recruitment and interview process of new center medical and laboratory directors.
• Collaborate with the Corporate Medical Director and Corporate Legal Department to manage the contracts for the center medical and laboratory directors.
• Be responsible for coordinating the training and certification of new medical and laboratory directors on the applicable Standard Operating Procedures (SOPs).
• Provide medical expertise in the review of donor adverse events and contribute to company and industry Plasmavigilance activities.
• Collaborate with the Corporate Medical Director and Regulatory Affairs to lead the investigation for donor fatalities.
• Coordinate with regional and collection center leadership to ensure adequate physician coverage for all centers including planned or unplanned absences of the center medical and laboratory directors.
• Collaborate with the Corporate Medical Director to establish the expectations and goals for the Bio Supplies Medical Department.
• Collaborate with the Corporate Medical Director to manage the medical department budget and contribute to the annual budget planning process.
• Collaborate with the Corporate Medical Director and Bio Supplies Quality to identify and implement quality improvement projects for the medical department.