Director, Plasma Medical Department

GRIFOLS, S.A.•Lake City, KS

6d•Onsite

About The Position

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, Plasma Medical Department provides medical oversight and guidance for source plasma, whole blood, blood component, and specialty plasma collection centers and their corresponding medical directors, laboratory directors, and medical staff. The human-derived blood and plasma collected at these centers are used in the production of plasma-derived medicines to treat patients with chronic, rare, and prevalent diseases that can be life-threatening. The Director may also serve as a center medical and / or laboratory director for a Plasma Procurement collection center(s) with all the responsibilities pertaining to that position.

Requirements

Medical Degree (MD or DO) required.
Current, unrestricted physician license in the State of work required and licensing in multiple states may be requested as needed.
Qualified under current CLIA regulations to serve as a Laboratory Director for a laboratory performing moderate complexity testing.
Typically requires 5 years of related experience.
Skill, competency, and performance as Center Medical Director, as well as prior experience in a leadership position may be considered in place of the stated requirements. For example: a physician who has demonstrated excellent control of the medical operations of the donor center, or a physician who has also managed a medical clinic, a team in an urgent care or similar setting, or other applicable leadership experience, may be considered in lieu of 5 years of experience in the plasma industry. These cases are evaluated and approved exclusively by the Corporate Medical Director.

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, 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 Plasma Procurement 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 Plasma Procurement Regional and Geographic Leadership Teams.
Provide medical oversight, guidance and subject matter expertise to all source plasma, whole blood, blood component, and specialty plasma collection centers to maintain a homogenous approach to donor selection across Biomat USA as established by the Medical Department.
Manage and supervise any other medical support staff for the Plasma 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 Plasma 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 Plasma Procurement Quality Department to identify and implement quality improvement projects for the medical department.
Collaborate with the Corporate Medical Director and Plasma Procurement Operational Leadership to identify and implement projects that contribute to improved operational efficiency and donor experience.
Be available to assist center leadership and the Plasma Procurement Quality Department, as needed, in the development of corrective action plans.
Review internal and external audit reports of the Plasma Procurement donor centers to assist in the formulation and evaluation of the goals and objectives of the Plasma Medical Department.
Assist the Corporate Medical Director and Training Department with the development of training manuals created for the different roles within the medical department, as well as the specialty programs.
Assists the Corporate Medical Director and Specialty Plasma Programs Leadership with oversight of the Specialty Plasma Programs at the donor centers.
Assist the Corporate Medical Director with the regular review and update of all written medical guidelines to be used at the donor centers to maintain a homogenous approach and keep updated with regulatory changes and medical advances.
Be responsible for the oversight of the preparation, conduct, and administration of a research study or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.
May serve as a backup for a Director, Plasma Medical Department or the Center Medical and Laboratory Director for any Biomat USA donor center as needed.
Regularly communicate with the Corporate Medical Director regarding the centers assigned to provide medical support and oversight.
Conduct activities in a responsible and ethical manner according to accepted medical standards to ensure donor safety and product safety.
Conduct activities in accordance with Grifols' history, values and mission to ensure donor safety and product safety.
May represent the company at industry associated activities and events, including the active participation in special committees and task forces as needed.
May serve as an instructor at the Grifols Academy.
Assists Corporate Medical Director as needed with other duties as assigned.
Performs Clinical Laboratory Improvement Amendments (CLIA) related Laboratory Director duties as needed.
Performs at the expert level for all duties of the Center Medical and Laboratory Director.
Participates in Management meetings.
Provides technical direction to others.
May participate in the interview process of new hires.
May provide input into Performance Management Process and participate in employee performance counseling as requested and supervised by the Corporate Medical Director.
Acts as a resource for others and is a designated trainer.
May provide general guidance to center staff related to donor eligibility, donor safety, and product suitability.
Prepare all necessary files, records, etc., to support Medical Director activities during center visits.