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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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