Primary responsibility for providing executive leadership and managerial direction to a program that is diverse in scope (inadvertent and as well as intentional contamination of food, dietary supplement and cosmetic products with pathogenic microorganisms and chemical and natural toxins); the nature of remedies for violations (recalls, injunctions, seizures, prosecutions, and warning and untitled letters); and the nature of individuals and communities served (American consumers and food producers, growers, transporters, and manufacturers).
Primary responsibility for providing executive leadership and managerial direction to professional, technical, and support personnel engaged in a variety of substantive activities related to food safety and food defense compliance enforcement activities. These activities include the planning, development, administration, execution and coordination of food safety and food defense field compliance programs; and food, cosmetic and dietary supplement related recalls and regulatory actions, including injunctions, seizures, prosecutions, and warning letters.
Collaborates with other senior Foods Program or Agency officials in the formulation, development, and execution of short and long range goals to increase compliance with food safety regulations and to reduce the incidence of foodborne illness and disease threats in the U.S.
Participates in and contributes to top level Center, Agency, or Department discussions, meetings and conferences on broad regulatory matters and issues. These activities may involve precedent-setting matters and may be issues with high visibility and of particular concern to the Center Director and Deputy Commissioner for Foods, as well as the public.
Serves as a principal Foods Program point of contact for information concerning intra-and interagency coordination of compliance and enforcement actions pertaining to foods, cosmetics, and dietary supplements. Develops, prepares and presents authoritative memoranda, briefings, position papers and other materials concerning substantive questions, issues, findings, conclusions and proposed solutions and suggested courses of action based on the evaluation of all scientific, legal and regulatory information available.
Advises the Center Director, Deputy Commissioner for Foods and other FDA officials on legal, administrative, and regulatory approaches and administrative policies concerning implementation of the FDA Food Safety Modernization Act provisions pertaining to risk-based inspections, use of new enforcement tools, and mandatory recall authority. Oversees activities relating to development of methodologies to identify high risk food establishments for inspection purposes.
Represents CFSAN and the Center Director and initiates, establishes and maintains cooperative and collaborative relationships and participates in meetings and conferences with top level Center, Agency, or Departmental officials, industry representatives, program directors, senior scientific and subject matter experts, representatives from counterpart executive governmental departments and independent agencies, State and local health and regulatory officials, and others to: Secure and provide information concerning ongoing or proposed activities that may affect the conduct, coordination, execution and administration of Center policies and programs; discuss questions, problems and issues involving programmatic considerations and/or integration of Center resources or programs; present authoritative recommendations and conclusions reflecting the Center Director's view and/or the Center's position in related program matters; and to develop courses of action and alternatives to avoid, eliminate or mutually resolve actual or potential problems and issues. Provides policy and technical advice and assistance to industry and to other federal, state and local public health officials on issues related to the safety of foods.