Zada Giles
Summary
Professional with demonstrated expertise in animal food regulatory compliance and policy enforcement. Skilled in organization, project management, and cross-cutting collaboration. Known for reliability, adaptability, and strategic problem-solving. Recognized for taking a proactive approach to identifying and addressing areas for improvement with a focus on optimizing processes and supporting team objectives. Committed to safeguarding human and animal health and the success of the organization while adhering to CVM's core values: We serve, we lead, we learn, we honor.
Overview
17
17
years of professional experience
Work History
Compliance Officer and Subject Matter Expert
FDA-Center for Veterinary Medicine
06.2022 - Current
- Serves as technical authority on complex compliance matters providing expert advice concerning regulatory approach and enforcement options.
- Serves as a Point of Contact to the FDA/OII Animal Food Inspectorate and state partners during violative inspections.
- Represents CVM Division of Compliance during meetings with regulated industry, regulatory partners, and professional organizations.
- Coordinates, communicates, and collaborates with FDA Inspectional staff, state counterparts, and other FDA Center personnel to ensure policy and program requirements are met as well as provide consistency across the agency in implementing regulations.
- Evaluates case submission documents to ensure they include supportable evidence of significant violations.
- Reviews proposed violation letters for proper format and content and provides feedback to other Division of Food Compliance compliance officers.
- Collaborates with cross-functional teams to create new procedures and processes to address changing roles and responsibilities.
- Developed and provided compliance management system training to increase employee skillsets and streamline task work flow.
Compliance Officer
FDA-Human and Animal Foods, East-5 (HAFE5)
05.2018 - 06.2022
- Applied Consumer Safety expertise to review and evaluate adequacy of evidence and compliance documents for human and animal food/feed, including medicated feeds.
- Prepared and reviewed responses to inquiries from other Federal, State, or local agencies, regulated industry, and importers regarding interpretations of Agency enforced laws and regulations, case status, and enforcement policies.
- Advised and assisted management on regulatory and compliance matters related to human and animal food/feed.
- Provided technical direction necessary to ensure effective accomplishments of inspections.
- Served as back-up Recall Coordinator.
- Chosen to participate on a cross-cutting Course Advisory Group to create an evidence development course for FDA stakeholders covering inspectional activities in produce and human and animal food.
- Maintained a comprehensive understanding of precedent-setting and emerging issues associated with human and animal food/feed and drugs by participating in conferences, seminars, and training.
- Interpreted laws, regulations, and policies related to human and animal food/feed to routinely formulate regulatory recommendations for OCC and regulated industry in areas such as labeling, record keeping, manufacturing, and recalls/refusals.
- Collaborated with FDA laboratories to request and review analysis of scientific data to determine the validity, quality and suitability for use when assessing compliance with good manufacturing practices and preventive controls.
Supervisory Consumer Safety Officer
FDA-HAFE5
05.2016 - 05.2018
- Performed the technical, administrative and personnel management functions for a staff consisting of Consumer Safety Officers and Consumer Safety Technicians engaged primarily in inspectional, investigational or sampling assignments within the food program area.
- Food program monitor responsible for allocating resources, coordinating sampling teams, monitoring yearly work plans, and ensuring strategic goals were met.
- Responsible for allocating inspection assignments for the states of TN and AL under state partnership contracts.
- Reviewed and evaluated evidence and information gathered during inspections, final reports, and sample results to determine if compliance should be notified.
- Served as the point of contact to industry, state, and federal personnel for European Union and China export lists for the states of AL, MS, LA, and TN.
- Participated with the Branch Director in the establishment of goals and priorities for the branch.
- Represented HAFE5 after program realignment on a policy reconciliation work group to ensure procedures and processes were uniform across divisions.
- Established guidelines and performance expectations for staff, which were clearly communicated through the formal employee performance management system and recurring meetings.
Consumer Safety Officer
FDA-New Orleans District
01.2010 - 05.2016
- Plan and coordinate in-depth regulatory inspections and investigations in FDA regulated industries primarily in human and animal drugs and dietary supplements.
- Audit the effectiveness of firms' quality control systems and operations.
- Analyze and evaluate procedures, scientific data, and records gathered during inspections and investigations to recommend enforcement actions to FDA management and compliance.
- Interpret and apply the Food, Drug, and Cosmetic Act and other regulations to ensure compliance.
- Respond to inquiries and exchange information with federal, state, and local agencies regarding FDA regulations to provide guidance, solve problems, and clarify polices.
- Served as an Import Consumer Safety Officer responsible for reviewing entry documents to determine admissibility for imported FDA regulated products and informing other federal agencies and regulated industry of findings and recommendations resulting from field examinations and sample collections.
- Professionally interact with and advise various levels of officials representing establishments subject to regulatory review.
Acting Branch Director
CVM-Investigations and Compliance Action Branch
05.2023 - 08.2023
- Performed the administrative and human resource management functions relative to the staff supervised including planning, coordinating, and evaluating the programs and activities of the staff.
- Obtained resources, identified strategic objectives, defined jobs, and assigned work.
- Planned, organized and directed complex investigations involving response and recovery of adverse events associated with FDA regulated products.
- Managed the technical accuracy of compliance-based cases and/or actions involving animal food, which includes animal feed, pet food, and raw materials and ingredients.
- Managed the consistent application of staff members' regulatory, compliance-based work to ensure interpretations and recommendations provided by employees were uniform and aligned with FDA and CVM regulatory compliance policy and objectives.
- Confirmed applicability of guidelines and policy used by staff members in the performance of their investigative and/or enforcement work, reviewed scientific and technical data, and provided guidance and/or outreach to pertinent stakeholders particularly when guidelines were unclear or precedents.
- Solved complex problems by researching and evaluating options and consulting with other professionals within and outside FDA and CVM as necessary.
- Briefed the Division Director and staff on all regulatory interpretations and analyses and provided expert advice on the development of policy impacting the agency's mission.
- Participated in meetings with the Division Director and other Center officials, and when appropriate, the Agency, on problems related to compliance investigations, enforcement actions, as well as other functions under the purview of the Division.
- Advised professionals and officials in other FDA and CVM organizations with programs interrelated on matters of regulatory compliance.
Acting State Liaison
FDA-New Orleans District
11.2014 - 12.2014
- Oversaw state contracts for TN, MS, AL, and LA.
- Wrote and coordinated with state regulatory partners on partnership agreements including allocation of resources and inspectional obligations.
- Scheduled audits with the state regulatory partners and monitored audit classifications.
- Reviewed state inspection reports and quarterly reports; ensured state regulatory partners met time-frames and contract obligations.
- Organized work planning meetings with state regulatory partners and represented the New Orleans District at these meetings.
Pre-Approval Manager
FDA-New Orleans District
01.2013 - 12.2013
- Reviewed incoming New Drug and Abbreviated New Drug Applications; evaluated previous inspection reports and firm regulatory history to determine if an inspection was required.
- Assigned inspections to the investigations branch and forwarded the district's final recommendation to the Center for Drug Evaluation and Research (CDER).
Forensic Scientist – Forensic Chemistry/Drug Lab
Tennessee Bureau of Investigations
04.2008 - 12.2009
- Performed a variety of laboratory tests to analyze and examine physical evidence such as tablets, powders, liquids, and plant material; utilized instruments such as GS/MS, GC/IR, FTIR, HPLC, and UV Spectrophotometer
- Reported laboratory findings in Laboratory Information Management System (LIMS)
- Collected evidence (i.e., fibers, tire tracks, shoe prints, etc.) for Microanalysis while serving as a member of the Violent Crime Response Team
- Trained to testify in court cases
Education
Bachelor of Science - Biology and Chemistry
Middle Tennessee State University
Murfreesboro, TN05.2007
Skills
- Subject matter expert in FDA animal food regulations, regulatory enforcement actions, and compliance enforcement strategies
- Strong background in managing and directing the development of enforcement strategies and precedent setting policy including CVM's Retail Food Establishment policy and CVM injunction casework
- Experience managing food programs including developing work plans, allocating resources, determining priorities, and ensuring strategic goals are met
- Experience supervising and managing animal food program staff including performance reviews, hiring and firing, and fostering a collaborative and empowering environment through coaching, training, and communication
- Excellent verbal and written communication skills
References
- Justin Henson, Branch Director, Field Operations and Investigations Branch, Division of Food Compliance, Office of Surveillance and Compliance, Center for Veterinary Medicine, Nashville, TN, 240-402-5635.
Timeline
Acting Branch Director
CVM-Investigations and Compliance Action Branch
05.2023 - 08.2023
Compliance Officer and Subject Matter Expert
FDA-Center for Veterinary Medicine
06.2022 - Current
Compliance Officer
FDA-Human and Animal Foods, East-5 (HAFE5)
05.2018 - 06.2022
Supervisory Consumer Safety Officer
FDA-HAFE5
05.2016 - 05.2018
Acting State Liaison
FDA-New Orleans District
11.2014 - 12.2014
Pre-Approval Manager
FDA-New Orleans District
01.2013 - 12.2013
Consumer Safety Officer
FDA-New Orleans District
01.2010 - 05.2016
Forensic Scientist – Forensic Chemistry/Drug Lab
Tennessee Bureau of Investigations
04.2008 - 12.2009
Bachelor of Science - Biology and Chemistry
Middle Tennessee State University
Similar Profiles
Carmela StamperCarmela Stamper
Health Communications Specialist/Veterinary Communications/Management Analyst at U.S. Food and Drug Administration (FDA) Center for Veterinary MedicineHealth Communications Specialist/Veterinary Communications/Management Analyst at U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine
Natalie MitlyngNatalie Mitlyng
Summer Research Student at Nc State College Of Veterinary Medicine & Veterinary HospitalSummer Research Student at Nc State College Of Veterinary Medicine & Veterinary Hospital
ANNA LUTZANNA LUTZ
Veterinary Receptionist at Medicine Man Veterinary Hospital, Pllc & Mobile Veterinary ServiceVeterinary Receptionist at Medicine Man Veterinary Hospital, Pllc & Mobile Veterinary Service
Lucia WilsonLucia Wilson
Risk & Compliance Specialist II, Subject Matter Expert at Uber TechnologiesRisk & Compliance Specialist II, Subject Matter Expert at Uber Technologies
Kuthzie CoissyKuthzie Coissy
Subject Matter Expert/Escalations Specialist, Compliance at FiservSubject Matter Expert/Escalations Specialist, Compliance at Fiserv