Gabriel Muniz FDA Only Resume

1. GABRIEL MUÑIZ
Miami, FL
LinkedIn Profile
EXPERIENCE
10/2015 – PRESENT
SUPERVISORY CONSUMER SAFETY OFFICER, U.S. FOOD AND DRUG
ADMINISTRATION
As the first-ever supervisor of FDA’s Office of Regulatory Affairs (ORA), Tobacco Operations Staff
(TOS), I am responsible for collaborating with the Center for Tobacco Products (CTP) on
compliance and enforcement activities for the tobacco program and to implement policies
relating to the Federal Food, Drug, and Cosmetic Act and the Family Smoking Prevention and
Tobacco Control Act to regulate the manufacture, distribution and marketing of tobacco
products. In this capacity, I am responsible for the strategic development of the tobacco
program and for operational oversight of staff responsible for conducting inspections,
investigations, and compliance activities.
My accomplishments and impacts include:
Strategic development of the tobacco program:
• Apply tobacco program expertise and fully participate in all phases of strategic program
planning with ORA senior leadership to develop and implement the tobacco program
policies and objectives, short and long-term goals, and operating policies to achieve the
mission of the Agency to protect the public. For example: development and execution
of the tobacco program work plans for FYs 2016 to present, Tobacco Field Committees
for FYs 2016 to present, and inspection and investigation assignments.
• Collaborate with ORA’s Office of Management to formulate, monitor, and support the
tobacco program budget. I am responsible for the execution of a multi-million tobacco
program budget.
• In collaboration with CTP and ORA senior leadership, I contribute to the development of
the position descriptions, recruitment, and selection of an interdisciplinary tobacco
operations staff. Since 2015, I have supported the growth of the tobacco operations
staff from 5 FTE’s to the current staff of 15, consisting of 12 investigators, 1 compliance
officer, 1 program support assistant, and 1 supervisor.
• Apply my subject matter expertise of the tobacco program to review and analyze
proposed tobacco product regulations and policies to ensure that they are consistent
with the strategic goals and objectives of the tobacco program and consistent with ORA
policies and practices, for example, the deeming regulation, the proposed tobacco
product manufacturing practice regulation, the proposed administrative detention
regulation.
Operational oversight of the tobacco program:

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• I am responsible for conducting periodic review of the progress and accomplishments of
the tobacco program and provide reports to ORA senior leadership. The
accomplishments of the tobacco program include:
- FY2016: Successfully completed 102% of the workplan obligations for inspections;
140% of the workplan obligations for investigations.
- FY2017: Successfully completed 104% of the workplan obligations for inspections;
143% of the workplan obligations for investigations.
- FY2018: Successfully completed 136% of the workplan obligations for inspections;
100% of the workplan obligations for investigations.
• Monitor the progress of the tobacco program in terms of resource allocation and funding
requirements.
• Continuously manage and direct the field activities of 14 Tobacco Operations Staff,
consisting of 12 investigators, 1 compliance officer, 1 program support assistant. This
includes managing all employee resources issues, i.e., equal opportunity, ensuring a safe
and healthy work environment, assigning work, reviewing and approving/rejecting work
products, approving leave, establishing training to ensure that technical competence is
maintained and promote employee career development, directing actions to correct
performance deficiencies, conducting and approving performance appraisals, and
initiating and approving performance awards.
• Reviewing and approving classifications of all work products and proposed enforcement
actions to protect the public health. The enforcement accomplishments of the tobacco
program include:
- Multiple Official Action Indicated (OAI) classifications, resulting in over a dozen
Warning Letters, all of which are the first-of-its-kind actions.
- Multiple recalls and emergency response activities have been completed since
FY2016.
- Multiple consumer complaints have been successfully investigated since FY2016.
The position reports directly to the Assistant Commissioner for Medical Products and Tobacco
Operations.
04/2015 – 6/2015
CONSUMER SAFETY OFFICER (TEAM LEAD - TOBACCO CADRE), U.S. FOOD AND
DRUG ADMINISTRATION
Lead investigator who acts in the capacity of a first line supervisor for the Tobacco Cadre
investigators.
The incumbent is considered the top program expert and has:
• Mastered the principles, practices, and theories utilized in the production of tobacco products
(equipment, manufacturing, processing, control and testing methodology) to serve as a technical
authority in processes, analysis, behavior, risks and the impact of the processes of the tobacco
products; provide authoritative advice and assistance on extensive, complex, and complicated
manufacturing processes and operations, and inspectional problems relative to the tobacco
products; recognize any discrepancies or inconsistencies between information reported and
made available and the true nature of the manufacturer being inspected or investigated; and,

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provide written analyses of data and in-depth fault analysis evaluations and product failures
aimed at preserving and protecting the public health.
• Broad knowledge of a variety of various scientific and technical disciplines to carry out tasks
related to the regulation of the tobacco industry and related test instrumentation.
• Knowledge of written and verbal communication practices and principles to prepare and
present written reports, findings, and recommendations~ develop analyses that are used for
presentations and as instruments for negotiation; conduct negotiations with industry
representatives and other government agencies; and, develop formal training programs.
• Comprehensive knowledge of the Food, Drug, and Cosmetic Act, PHS Act, The Family Smoking
Prevention and Tobacco Control Act and other implementing rules and regulations, licensing
processes and court precedents which apply to the area of assigned responsibility. Skill to
interpret these laws, policies, etc., and their application to the broad field of tobacco products.
The position reports directly to the Director in the Office of Medical Products and Tobacco
Operations.
05/2014 – 10/2015
CONSUMER SAFETY OFFICER (TOBACCO CADRE), U.S. FOOD AND DRUG
ADMINISTRATION
This position represents an expert level within ORA for the inspection and investigation of
Tobacco products, firms and facilities sufficient for the incumbent to assume primary
responsibility for carrying out inspectional or investigational assignments in the Tobacco Cadre.
Assignments are of such complexity to require the incumbent to possess comprehensive
knowledge of the science related to the Tobacco products functional area, as well as an intimate
knowledge of industry practices which have been acquired by extensive, complex technical
training and/or experience in investigations and inspections.
Specifically the incumbent: serves as a technical expert in inspectional and investigative
techniques in the specialized functional area of Tobacco products with responsibility for
conducting comprehensive foreign or domestic Inspections and investigations of FDA regulated
Tobacco industry firms and manufacturing facilities, foreign and domestic, as well as for
providing expert advice to ORA management, the CTP and other ORA specialists nationwide;
conducts special complex studies; inspections and investigations, such as possible adulteration,
misbranding or illicit trade of Tobacco products; participates in developing and conducting,
within the tobacco program area, specialized, highly technical and complex training courses to
investigators selected on a nationwide basis, including investigators and personnel from various
state and foreign governments and regulated industry; is consulted in matters pertaining to the
promulgating of regulations and reviews and comments on the feasibility or desirability of draft
proposals; participates in the formulation and development of inspectional and investigational
procedures and techniques pertaining to problems within the functional program area.
The position reports directly to the Deputy Director in the Office of Medical Products and
Tobacco Operations.
01/2009 – 5/2014

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CONSUMER SAFETY OFFICER (GENERALIST), U.S. FOOD AND DRUG
ADMINISTRATION
Concentration: Biologics, Food (Seafood HACCP Level II Certified / Interstate Travel Program (ITP)
Investigator), Medical Device, Bioresearch Monitoring (BIMO), Emergency Response (Florida
Planning Section Chief), and Florida State Inspector Auditor (FDACS).
Duties:
Investigating complaints of injury, illness, or death caused by a product regulated by the FDA;
Initiating actions against violators; advising and training industry, State and local officials and
consumers on enforcement policies, methods, and interpretation of regulations and their impact
on public health; Developing, drafting and coordinating clearance and issuance of Federal
Register rules and notices, as well as citizen petition responses; policy guidance; Applying the
Freedom of Information Act (FOIA) and the Food, Drug and Cosmetic Act(FD&C) to a variety of
requests for information concerning FDA's scientific/regulatory activities; and other consultations
concerning regulatory matters; Plan and direct regulatory programs and/or develop inspections
of regulated industry, or manage and coordinate the review process of marketing applications.
The position reports directly to a first line supervisor at the Miami Resident Post within the
Florida District Office.
EDUCATION
APRIL 2007
BACHELOR OF SCIENCE – HEALTH SCIENCE, FLORIDA INTERNATIONAL UNIVERSITY
FDA AWARDS
• May 2019 - Group Recognition Award - For
outstanding teamwork in coordinating a
precedent-setting warning letter preventing the
illegal manufacture and sale of unapproved new
tobacco products resembling kid-friendly foods.
• August 2016 - Group Recognition Award - For
developing complex scientific evaluation and
communication plans to support the first FDA
pre-market tobacco application (PMTA)
marketing authorization.
• June 2011 - Group Recognition Award - For
exceptional coordination, cooperation and
performance during three medical device QSIT
inspections that resulted in a Mass Seizure of
dental medical devices.
• June 2017 - Commissioner's Special Citation
- For demonstrating scientific expertise,
teamwork, and innovation in the review of
Modified Risk Tobacco Products
Applications.
• July 2013 - Group Recognition Award - For
exemplary planning and execution of the
food safety mission for the Republican and
Democratic National Conventions through
the successful integration of local, state and
federal resources.
SKILLS
Knowledge in eNSpect, OSAR, FACTS, FURLS (TRLM), ORADSS, OASIS, MARCS-CMS, QMiS, ECMS, iTRAC,
CTP Business Objects, GIS / GeoWeb, TOS Dashboard, ITAS, eCORPS, Concur (CGE), Sharepoint, Minitab
15 Statistical Software, TE Acceptance Sampling Programs, Test Sample Normality Software, etc.