Chief Medical Officer

1 week ago

Lubbock, Texas, United States CSL Plasma Full time

Position Overview
As the Chief Medical Officer, you will provide essential medical guidance to our Medical Staff Associates, ensuring the highest standards of care and compliance. You will typically hold the position of the primary physician registered as the Laboratory Director with the Food and Drug Administration (FDA).
Key Responsibilities
+ Act as the principal physician responsible for reporting to the FDA, ensuring adherence to all relevant Federal and State regulations, including Title 21 of the Code of Federal Regulations. You will monitor the medical compliance of the center and either fulfill or delegate the responsibilities of 'laboratory director', 'technical consultant', or 'clinical consultant' as outlined by the Clinical Laboratory Improvement Act of 1988 (CLIA).
+ Ensure that all necessary training and proficiency testing related to CLIA/COLA is conducted, including the oversight of hematocrit and total protein testing, along with the maintenance of standardized logs.
+ Uphold and comply with all CSL Plasma Services policies and procedures, maintaining exemplary medical standards and ensuring compliance with current Good Manufacturing Practices (cGMPs) through active involvement with center management and quality units.
+ Provide medical oversight and training to Medical Staff Associates, with the option to delegate training responsibilities to qualified personnel. Evaluate newly trained Medical Staff Associates for certification recommendations.
+ Conduct weekly reviews of Medical Staff Associates' notebooks, including assessments of screening medical evaluations and communication of unsuitable test results.
+ Facilitate monthly meetings with Medical Staff Associates to discuss relevant medical topics, documenting each session. Collaborate with the Center Manager and Compliance Specialist during weekly center visits and participate as a member of the Quality Assurance Team.
+ Serve as a communication link between the Corporate or Divisional Medical Director and the Center Medical Staff, preparing monthly reports and engaging in periodic conference calls.
+ Address inquiries regarding donor suitability for long-term plasmapheresis, providing guidance to Center Medical Staff on donor-related questions. Conduct confidential interviews with donors to gather necessary information.
+ Maintain confidentiality concerning employee, donor, and center records throughout all duties performed. Oversee the maintenance of medical supplies and emergency equipment.
+ Review and approve moderate and severe medical incident reports before allowing donors to resume donating. Assess abnormal test results, including serum protein electrophoresis (SPE) results, and document decisions regarding donor eligibility.
+ Ensure the health and safety of donors participating in immunization programs, if applicable, and monitor their clinical responses.
+ For red cell recipients in the Anti-D Program, conduct qualifying evaluations, including obtaining consents and performing medical histories and physical exams prior to enrollment.
Qualifications
+ MD or DO degree from an accredited medical or osteopathic institution.
+ Must hold a current and active medical license in the state where the center operates.
Experience
+ A minimum of one year of residency training as an MD or DO.
About CSL Plasma
CSL Plasma is a leading global collector of human plasma, dedicated to ensuring that individuals with rare and serious diseases can lead healthy lives. We are committed to our mission, as lives depend on our work. We embrace diversity and inclusion within our workforce, reflecting the communities we serve. Learn more about our commitment to diversity and inclusion at CSL.

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