Center Medical Director- Back up (Licensed MD or DO Physician) (Dallas)

Center Medical Director - Backup Contractor

Job Title: Center Medical Director- Back up (Licensed MD or DO Physician)

Company Overview

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands‑on approach to production and development that sets us apart.

Job Description

This position reviews and approves all policies and procedures related to donor suitability, donor collection, and donor safety. It assists the Medical Director with managing medical staff regarding determination of donor suitability, donor collection, and review of donor test results. It provides guidance on a day‑to‑day basis regarding donor safety issues and may act as the center’s CLIA Technical Consultant. The alternate medical director must be on‑site as needed based on the needs of the center. It follows all FDA, CLIA, and OSHA policies and procedures, maintains confidentiality of all personnel, donor, and company information, assists with administrative duties to support the Donor Center, and maintains compliance with procedures and regulations while following current Good Manufacturing Practices.

Job Functions

• Perform new, return applicant, and annual donor physicals for all donation programs including donor immunization programs and disease state programs.
• Administer informed consents for all donation programs including donor immunization programs and disease state programs.
• Order immunizations and evaluate the clinical response to immunizations for donors on immunization programs.
• Order immunizations and evaluate clinical response to employees Hepatitis B immunizations.
• Administer the HIV Bulletin and assess donor understanding of high‑risk behaviors.
• Maintain medical records in accordance with SOPs and cGMP.
• Train physician substitutes in accordance with the physician substitute training program.
• Assess the performance of new physician substitutes and give final approval for them to work independently.
• Assist with assessing the competence of physician substitutes on an annual basis.
• Complete donor reviews in accordance with the timelines established in the SOPs and enter the 14‑Day SPE results into the applicable donor center system in accordance with SOPs.
• Review all Level 2 and 3 Medical Incident Reports and abnormal test results and take appropriate follow‑up actions.
• Communicate any compliance or risk areas to the Center Director and Quality Assurance.
• Participate in monthly QA meetings.
• Provide confidential counseling to ineligible donors when necessary.
• Report all unsafe situations or conditions to the Center Director.
• Perform all other duties as assigned by management.

CLIA Technical Consultant Responsibilities

• Establish and maintain QA/QC programs, including taking remedial action when performance deviates from established standards.
• Enroll the laboratory in a CMS (Centers for Medicare & Medicaid Services) approved proficiency testing (PT) program, ensure PT is performed per CLIA requirements, submit results on time, and ensure staff review PT reports and implement corrective actions when needed.
• Ensure personnel are properly trained and competent before performing patient testing; maintain ongoing competency assessment; and identify, provide, and document remedial training as necessary.

Job Requirements, Qualifications, And/or Experience Requirements

• Current MD or DO license in the state where the Donor Center operates.
• For CLIA Technical Consultant: MD certified in Pathology or Hematology or have at least one year of experience directing or supervising non‑waived laboratory testing, or completion of an approved training course with at least 20 continuing medical education (CME) credit hours in laboratory practice.
• CPR BLS Certification.
• Annual GMP training.
• Strong organizational skills.
• Strict adherence to current good manufacturing procedures.
• Strong communication skills, both verbal and written.
• Ability to interpret medical information to formulate appropriate actions.
• Occupational exposure to blood‑borne pathogens.
• Work requires extended periods of standing and bending.
• Ability to train others is required.