The Director of Standards is responsible for managing the activities of the AATB Standards Department. This includes providing support and guidance to the AATB Standards Committee and associated work groups. The Director of Standards provides expert regulatory and quality advisory services to the AATB staff, members, and relevant external individuals on standards and regulations in tissue banking and related areas. Responsible for ensuring the accurate and timely publication of the AATB Standards for Tissue Banking.
Acting as Secretary and AATB liaison, both support and direct the Standards Committee in ongoing updates to and modifications of all AATB Standards. Responsible for scheduling and coordinating Standards Committee meetings, maintaining minutes, and ensuring the roster is accurate.
Responsible for addressing AATB inquiries received related to standards, regulatory or other content produced, distributed, or known by AATB related to standards and/or guidance documents produced by AATB for membership.
Works with VP of Accreditation and Standards and other AATB department staff to design and execute projects that support membership for Standards and policies.
Works with representatives from Governmental agencies to ensure effective compliance with current and emerging regulations.
Responsible for strategic initiatives that result in optimized services for members and support future growth for AATB Standards.
Responsible for maintaining the files for the Standards Committee and committee subgroups.
Responsible for maintaining minutes and summarizing content from all Standards work groups and distributing them to relevant committee members in a timely manner.
May be asked to be a staff liaison to other AATB Committees and/or Councils.
Required Competencies and Interpersonal Skills
Must possess in-depth knowledge, understanding and experience with interpretation of FDA regulations, ISO standards, and other governmental regulations and standards associated with tissue banking, medical devices, drugs and/or biologic products.
Ability to work with minimal supervision, take initiative and make independent decisions with a high degree of critical thinking.
Highest level of professionalism with the ability to maintain confidentiality.
Expert level skills in professional communications with a multi-faceted customer group and ability to positively problem solve where differing opinions may be varied with internal and external stakeholders.
Demonstrated ability to develop and deliver presentations to a wide range of constituents and audiences.
Proven ability to manage time, prioritize multiple tasks, meet deadlines, and maintain high-quality attention to detail.
Proficient in software applications required to support job duties.
Work Environment including Physical Demands
This position may be remote or based at the AATB corporate office.
This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.
Position Type/Hours of Work
The normal work schedule for all employees is eight hours a day, Monday through Friday. Core business hours are 10 am – 4 pm Eastern Time. Staffing needs and operational demands may necessitate variations in starting and ending times, as well as variations in the total hours that may be scheduled each day and week.
Occasional travel may be required at the discretion and approval of the supervisor.
AATB provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Additional duties may be assigned based on evolving department needs and at the discretion of the association.
Required Education and Experience
Bachelor’s degree in a relevant field with certification in quality and/or regulatory preferred.
Minimum of 10 years experience working in the tissue, medical device, drug, and/or biologics field.
Known in development or management of standards in relevant fields.
Equivalent experience may be considered at the discretion of the association.
The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific, and educational organization. AATB is the only national tissue banking organization in the United States, and its membership totals more than 120 accredited tissue banks and over 6,000 individual members. These banks recover tissue from more than 58,000 donors and distribute in excess of 3.3 million allografts for more than 2.5 million tissue transplants performed annually in the US. The overwhelming majority of the human tissue distributed for these transplants comes from AATB-accredited tissue banks.