This position is located in an FDA District Office or Resident Post, and represents the highest level of expertise in a district for the inspection of firms engaged in the manufacture, processing, and control of human or veterinary pharmaceutical products, for compliance with FDA laws and regulations. Assignments will involve inspections/investigations across District lines. As a Program Manager, is a primary source of expertise in an assigned geographical area who resolves the most difficult, controversial and complex inspectional problems which involve a combination of scientific and regulatory responsibilities. Major duties includes:
· Serves as a principal source of expertise within a geographical area provides extensive advisory, liaison and consultative services for drug programs to regulated industries, State agencies, other Federal agencies and Agency management.
· Advises on new advances in technology related to drug products, new programs, laws and regulations, significant court decisions, and any new trends or scientific findings involving drug products.
· Meets with hostile or uncooperative industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review with emphasis on deficiencies. Interactions require considerable tact and firmness to obtain needed information regarding submissions.
· Develops, monitors, coordinates, and implements FDA Agency policy and initiatives in relation to human or veterinary pharmaceutical products ensuring compliance with FDA laws and regulations.
· Conduct quality assurance inspections of domestic and international manufacturing processes and write establishment inspection reports and recommendations for classifications.
· Plan, conduct and direct highly technical, complex inspections related to production, control, testing and processing human or veterinary pharmaceutical products.
· Perform investigations involving complaints or injury/death.
· Conduct complex and in-depth investigations, determine required course of action and level of investigative efforts required.
· Document inspection findings in prescribed written format according to FDA policies and guidelines.
· Maintain a working knowledge and awareness of the Current Good Manufacturing Practices objectives and exercise analytical judgment to anticipate potential problems.