Under minimal direction, works with other HLA Laboratory
Directors and Senior CMA leadership to plan, direct and coordinate
the overall operation and administration of assigned Human
Leukocyte Antigen (HLA) Laboratories, as outlined by ASHI,
including but not limited to being qualified to oversee each area
of accreditation sought by the laboratory and each technology
offered by the laboratory. This position promotes Vitalant's
mission, vision, quality policy, and strategic initiatives to
position Vitalant as a Center of Transfusion Medicine and Cellular
DUTIES AND RESPONSIBILITIES:
Performs all assigned duties in compliance with internal SOPs
and external regulations. Brings compliance issues to the attention
of management. Keeps up to date on all training assignments.
Assures quality customer service to all customers.
Must maintain active credentials, certifications and/or
licenses, and associated continuing education, including any
state-specific licenses and/or credentials or client (hospital)
privileges, required to perform assigned duties per the Medical and
Laboratory Director Responsibilities Policy and which are required
for the performance of laboratory services in Medicare and Medicaid
reimbursed transplantation programs.
Responsible for the overall operation and administration of
assigned laboratories, including the employment of personnel who
are competent to perform test procedures, record and report test
results promptly, accurately and proficiently, and assure
compliance with the applicable regulations. Mentors and trains
staff as needed.
Supports the development, implementation and maintenance of the
Quality Assurance Program to ensure high quality services to all
customers and overall compliance with applicable regulations and
policies. Brings compliance issues to the attention of management
and works with them to address the issues promptly. Actively
participates in internal and external Management and Quality
meetings, including inspections and audits.
Accessible to the laboratory 24 hours a day, 7 days a week to
provide on-site and remote direction as needed, telephone and
electronic consultation commensurate with the workload. This
includes being available for performing virtual crossmatches as
necessary for the various solid organ programs. In instances when
the Director cannot be available, they must provide a qualified
designee. Supports other HLA laboratories as needed.
Responsible for the timely review and signing of reports of
laboratory results for physicians, hospitals and laboratory quality
Directs the overall clinical, technical, and scientific aspects
of assigned histocompatibility, immunogenetics and molecular
testing laboratories including tests performed for bone marrow and
solid organ transplantation.
Directs scientific development in molecular methodologies,
conducting research as appropriate. Develops and validates new
laboratory procedures as needed and publishes results in peer
reviewed journals as appropriate.
Directs the evaluation, development, implementation and
modification of existing and new laboratory testing services and
related operating procedures; makes recommendations for improvement
in the quality and analytical performance of testing services.
Uses various LIS/databases in a local and remote network
clinical lab environment. Abides by HIPAA and other security
expectations to protect patient and donor confidentiality in both
client hospital and laboratory settings.
Works with other HLA Directors, Laboratory Directors, and
Clinical Services leadership to standardize HLA laboratory and
general laboratory processes as much as possible.
Interacts with and develops partnerships with external
organizations to support the organization's strategic direction in
Attends and participates in service meetings for those
transplant programs actively utilizing the HLA laboratory,
including their respective Quality Assurance programs.
Provides scientific and technical direction and consultation to
external customers and Vitalant personnel in the areas of
histocompatibility, immunogenetics, and molecular technology.
Plans and implements educational training programs for both
internal and external audiences.
Helps develop and monitor operating budget for assigned area(s).
Applies for grants to fund research and development projects as
clinical responsibilities permit.
Remains abreast of changes and developments in the industry.
Establishes and maintains a network of professional relationships
both inside and outside the corporation. Represents the company
through participation in national, regional and/or local
Performs all other duties, at the discretion of management, as
Doctoral degree in biological science or licensed physician
ASHI qualified director required.
Knowledge of the grant application process preferred.
Knowledge of management principles including human resource
management, budget administration, financial analysis and business
Appropriate state and board certification (e.g., American Board
of Histocompatibility and Immunogenetics, American Board of
Bioanalysis, etc.) required.
ASHI certification preferred.
Four years post-graduate experience in immunology or cell
biology, two of which were devoted to formal training in human
histocompatibility testing in an ASHI accredited laboratory
Previous experience writing reports for scientific publications
in peer reviewed journals preferred.
Previous experience supervising junior Directors preferred.
Must possess the skills and abilities to successfully perform
all assigned duties and responsibilities.
Must be able to maintain confidentiality.
Attention to detail.
Strong organizational skills.
Strong oral and written communication skills.
Demonstrate proficient computer skills.
Ability to navigate electronic devices/equipment.
Ability to handle conflict and mitigate problems.
Interpersonal skills to interact effectively with internal and
Ability to read, write and speak fluent English.
Must be able to enter data into the computer.