Incumbent represents the highest level of expertise for inspections involved in FDA's bioresearch monitoring program including inspections of clinical investigators, sponsor/monitors, IRB's and GLP establishments for compliance with FDA laws and regulations. The incumbent is a primary source of expertise who resolves the most difficult and complex inspectional problems which involve a combination of scientific and regulatory responsibilities. Specific duties include:
· Plan, conduct and direct highly technical, complex and multi-faceted inspections and in-depth investigations.
· Make recommendations to regional and district management official as to whether or not a firm involved in the pre-market testing of products is in compliance with Current Good Manufacturing Practices (CGMP) and Current Good tissues Practices (CGTP).
· Review reports of inspections and investigations for violations and determine the sufficiency of the evidence.
· Provide extensive advisory, liaison and consultative services for biologic programs to regulated industries, State agencies, other Federal agencies and Agency management.
· Meet with (some time hostile or incorporative) industry representatives to exchange information and to provide advice and guidance regarding applications, notices, amendments, supplements or reports which fall within area of review and deficiency.
· Manage the review of previous approved products to determines whether continue to meet the current criteria.
· Conduct inspections and investigations of facilities where only limited guidance is available and proposed or new regulations is used to evaluate industry or, the investigation my results in considerable attention and review in the media, Congress or, other forces inside or outside the agency.
· Develop and implement formal training programs for agency personnel, industry, state and local officials and, provide technical expertise to industry.
· Conduct on the job training and serve as principal advisor and expert.
· Provide assistance on planning, coordinations and evaluating the bioresearch program.