The Vice President of Regulatory Affairs position is a professional senior management level position responsible for overseeing the security, accuracy and physical integrity of eye donor records and laboratory records. Emphasis of work is on continually initiating quality assurance and quality improvement programs to improve AEB policies, practices and procedures, particularly those addressing compliance with applicable Eye Bank Association of America (EBAA) and Federal Drug Administration (FDA) policies and procedures. All responsibilities should be performed within the scope of AEB’s mission and values and its Policy and Procedures Manual. This position reports to the Chief Technical Officer.
REQUIREMENTS & RESPONSIBILITIES-Develop and oversee Quality Assurance program including but not limited to: tissue retrieval, processing and processing controls, distribution, donor record generation, technical equipment maintenance and calibration, maintenance records, environmental controls, facilities, labeling, tissue storage, tissue evaluations, audits and lab inspections-Review donor files assuring accurate and complete data collection and entry-Submit all Adverse Reaction Reports with appropriate documentation to the FDA and EBAA with assistance from Chief Technical Officer.-Oversee and coordinate all EBAA and FDA inspections oCreate and submit any corrective actions necessary-Assist Chief Technical Officer with mock inspections-Perform quarterly audits for AEB regional offices-Maintain and submit annual FDA registrations for all offices-Oversee validation process and documentation-Maintain software validation in compliance with FDA requirements and assist VP of Information Services with creation and implementation of new or revised software configurations validation-Oversee AEB technical training programoEnsure current training files for employees are updated and accurate-Perform internal and external audits-Organize, update, and maintain regulatory books including but not limited to lab maintenance, supply reagent, validations, certifications and licenses, audits, event reports, CAPAs, and temperature monitoring-Investigate any departures, deviations and potential recalls/withdrawals -Oversee environmental monitoring and certification of clean rooms and biological safety cabinets-Perform investigations and create Corrective Action / Preventative Action Plans for Event Reports and Technical Observation Reports-Ensure all records regarding supplies and reagents are accurate -Assist in the analysis of data related to the pre-cut procedure, process and distribution as needed-Ensure all quality standards are met in donor records prior to distribution (Eye Bank Association of America, Food and Drug Administration and Alabama Eye Bank)-Work with Medical Director Designees to determine initial follow-up needed Perform Final QA on donor charts-Assist with the reviewing of technical SOPs and forms annually-Maintain SOPs and assist Chief Technical Officer and VP of Clinical Services with creation and implementation of new or revised policies and procedures-Assist VP of Transplant Services to confirm that required state licensing is accurate and submitted as needed (FL, CA, MD, NY, Canada, etc)-Perform yearly employee performance reviews- Assist with donor eligibility determination and follow-up- Maintain CEBT certification- Participate in CEBT call as neededEDUCATION & WORK EXPERIENCETo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill and/or ability required.- Certified Eye Bank Technician preferred- Minimum of five years eye banking experience preferred- Bachelor Degree in life sciences or R.N. degree preferred- Quality certification preferred- Two years experience in the health care field to include comprehensive knowledge of medical records regulation and medical terminology- Basic knowledge of Pharmacology/terminology- Basic knowledge of patient confidentiality laws-Current general knowledge of evaluation of tissue using slit lamp, specular and OCT- Familiar with FDA, OSHA and EBAA regulations and certification process.- Familiar with industry good manufacturing practices.- Willingness to work weekend/evenings to complete task- Position may require some holiday work- Demonstrates ability to interface effectively with doctors, nurses and other hospital personnel, and peers- Excellent communication skills including documentation and assessment skills- Valid driver’s license and insured automobileAbilities/Characteristics:- Computer literacy and familiarity with computer databases- Detail oriented- Strong organizational skills- Excellent oral and written communications skills- Superior interpersonal and public relations ability
Additional Salary Information: Competitive compensation and benefit package.
Our mission is about the restoration of sight, through timely recovery, excellent processing and efficient distribution of the highest quality eye tissue for transplantation, ophthalmic research and training. We are honored to have a strong history of being one of the top eye banks in the United States and continue to strive towards excellence to bring sight to the visually impaired. AEB is a 501...c3 non-profit. We are registered with the FDA and accredited by the Eye Bank Association of America.