As a Senior CSO in CDER’s Office of Quality Surveillance, I monitor the state of quality in the pharmaceutical supply chain using my CGMP expertise.

- Proven track record on reviews, data analysis, capability assessments, and outreach in the arena of Mutual Recognition of Pharmaceutical Inspections.

- Founding subject matter expert in Pharmaceutical Quality program in the emerging area of Mutual Recognition with EU Member States, report review, and capability assessments- Responsible for training, procedures, data analysis.

- Successful and high throughput referral of pharma cases throughout regulatory life cycle including case development through post action management for injunctions, warning letters, regulatory meetings, and recalls- Detailed at CDER's Office of Manufacturing Quality- Supervisory experience as Acting Director of Compliance Branch- State Outreach for New England States- Certified Level 1 performance auditor- Consults with internal and external stakeholders- Expert in trends and managing transitions

- Noted track record of identifying areas of concern on pre-approval and surveillance inspections supporting regulatory actions and approval decisions.- Recommended approvals and withholds on drug applications

- Dedicated specialized experience human and veterinary drug manufacturer and drug compounding inspections with withhold and compliance outcomes. - Detailed as Supervisory Investigator- Trained and mentored Investigators- Provided technical expertise to other departments and agencies on high profile cases

- Characterized relative expression and explored the structure and function of calcium-regulating proteins as targets for treatment of neuropathic pain at a small biotechnology firm.

- Established that anaesthetic doses of ketamine do not induce schizophrenia-like behavior in rats in the Turgeon Lab.

Designed printed circuit made with super conductor.