PROFESSIONAL BACKGROUND
25 Years of Experience
2016 - 2023
VICE PRESIDENT, MEDICAL DEVICE/COMBO PRODUCTS
Directed overall operations of complex remediation and enhancement compliance projects for multi-site/multinational organizations. Educated clients on total product lifecycle for pharmaceutical, medical device, and combination products. Advised clients in transition and enhancement of interim control measures and system capabilities. Devised strategic planning to utilize new technologies and services for improving quality standards aimed at consistent compliance and profitability. Lead high-functional teams and client projects through practical approaches to empower organization with team building, HR leadership, and operational excellence. Drafted and delivered presentations, lectures, training, blogs, and publications for industry and clients. Enhanced business expansion and compliance through customized, sustainable solutions.
2011 - 2016
DIRECTOR, INVESTIGATIONS
Headed Chicago District Investigations Branch of US FDA's Office of Regulatory Affairs. Led 70+ employees, overseeing domestic/import programs, inspections, investigations, sample collections, and emergency response programs of FDA regulated commodities. Managed compliance cases for supporting agency administrative and legal actions. Directed international inspections and quarterly work plans. Prepared branch budget aimed at cost minimization. Contributed to the successful delivery of multi-organizational projects, including Interpol; Office of Criminal Investigations; DEA; and USDA. Handled emergency operations, including natural disasters, epidemiological outbreaks, and national special events such as NATO/G8.
2006 - 2011
SUPERVISORY INVESTIGATOR
Supervised a team of Investigators working in all regulated commodities. Reviewed work for final disposition and/or recommendation to further compliance administrative and legal actions. Mentored and coached new Investigators in proper investigative practice, case development, investigative interviewing and compliance practices. Provided leadership and oversight of the Medical Device and Center for Veterinary Medicine program areas. Successfully developed organizational workplans, met quarterly and annual performance goals and maintained internal quality management standards. Provided instruction and training in medical devices through the Office of Regulatory Affairs training program for four years. Worked in close cooperation with state and local governments, DEA, USDA, and US Customs.
2000 - 2006
MEDICAL DEVICE SPECIALIST/ INVESTIGATOR
Investigator/Medical Device Specialist performed inspections and investigations of the most complex medical device, combination products and pharmaceutical manufacturers globally. Developed strong compliance cases resulting in Warning Letters, Seizure, and Injunction. Further supported investigations in cosmetics, dietary supplements, veterinary medicine, biomonitoring programs and imports.
AWARDS
Mexican Rice Response (Cross-Cutting)
Compounding Team
NATO Summit
Commissioner's Special Citation - Necrotizing Enterocolitis Group
ORA Mentoring Program Committee
Adulterated Chili Powder Seizure
Leveraging and Collaboration - ED Products Team
Adulterated Topical Antimicrobial
Outstanding Contribution to Basic Medical Device Course
Medical Device Consent Decree
Leveraging and Collaboration - Cronobacter Group
Tissue Residue Injunction
Center for Devices Special Recognition – GAMBRO
Leveraging and Collaboration - Medical Device Training Group
Outstanding Service Award - Triazine in Animal Feed
Botulinum Toxin Response
Pet Food and Animal Food Contamination Response
Commissioner's Special Citation - Liberty Shield
Commissioner's Special Citation - ORA Counterterrorism
Outstanding Service Award - Ephedrine Seizure Group.
Outstanding Service Award, United States Attorney's Office
TRAINING
United States Food and Drug Administration
Food, Drug & Cosmetic Act | Food and Drug Law | Evidence Development | Compliance Law I & II |
Medical Devices | Quality System Regulation | Industrial Sterilization | Process Validation | Pre-approval Inspections | Pharmaceuticals | Drug Manufacturing and Quality Control | Active Pharmaceutical Ingredient Manufacturing | Pre-approval Inspections | Foods | Basic Food GMP | Low Acid Canned Foods | Dietary Supplements | Foodborne Outbreaks | Nutrition Labeling | Food Safety Modernization | Feed Manufacturing | Tissue Residue | Management/Development | Supervisory Potential | FAME I - Leadership Skills | FAME II - Leadership Skills 2 | Personnel Practices for Managers (2006/2008/2011) | Emergency Response/Management | Incident Command for Single Resources and Initial Actions (200) | Incident Command System Overview (300) | NIMS/ICS Staff Training | Regional Incident Command and General Staff | ICS Position Specific, Incident Commander | ICS Position Specific, Planning Chief
American Management Association
Advanced Executive Leadership Program | Developing Executive Leadership | Advanced Leadership Communication Strategies | Leading with Emotional Intelligence | Situational Leadership II | Strategic Planning
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