---
title: 031
description: A consultant with The FDA Group.
---

[The FDA Group's Consultant Finder ](https://www.thefdagroup.com/find-consultants)

# [031](https://www.thefdagroup.com/find-consultants/031)

 Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Jul 12, 2022 6:07:24 AM

**PROFESSIONAL EXPERIENCE**

**FRESENIUS KABI**, Lake Zurich, IL 2019 to Current

**Senior Manager, FDA Compliance and Quality**

Directed GMP data integrity remediation and inspection readiness at Fresenius Kabi Maricao, Puerto Rico plant to address FDA 483/Warning Letter observations. Conducted and managed risk-based internal audits and external vendor audits for Lake Zurich and Maricao facilities.

- Lead Auditor GxP audits – contract manufacturers, CROs, internal facilities, labs, and suppliers.  
- Conducted mock FDA inspections, internal audits, and Gemba walks at Haina, Dominican Republic, Warrendale, PA, Lake Zurich, and Maricao, closing identified gaps within 30 days.
- Hosted FDA inspections and EU notified body audits by executing effective preparation management, TrackWise CAPA follow-up, and formal responses until closure.
- Launched FDA remediation at Marico via 5 teams, closing 85% of action items in 23 months. 

 

**THE FDA GROUP | INDEPENDENT CONTRACTOR**, Westborough, MA 2016 to 2018

**Pharmaceutical QA Consultant**

Provided GCP, GCLP, GMP, and GVP quality assurance support to Fortune 100 medical device and pharma firms to increase regulatory compliance and decrease regulatory authority inspection risk.

- Performed risk-based mock FDA/international authority inspections, internal audits, Gemba walks, and supplier audits at sponsors, CROs, CMOs, investigator sites, laboratories, and pharmacovigilance service providers.
- Optimized quality systems (quality manual, policies, SOPs, specifications, and work instructions), meeting current regulatory requirements for compliance and process improvements.

- Conducted risk-based GCP, GCLP, GMP, and GVP audits to ensure regulatory and guideline requirements (21 CFR Parts 11, 45, 46, 50, 54, 56, 58, 210, 211, 312, 314, 820, ICH-E6, ISO 9001, ISO 13485, ISO 14971, and EU MDR) are applied in systems, processes, and procedures.

 

**BIORASI CRO**, Miami, FL 2012 to 2016

**Vice President, Quality and Chief Compliance Officer**

Led Quality Assurance Unit and oversaw business operations for quality operations at Miami facility. Hired, trained, and evaluated new QA staff. Monitored QA services at US and international locations.

- Conducted and managed risk-based GCP, GCLP, GMP, and GVP audits in Europe, North America, and Russia, identifying risk, process improvement, with audit report turnaround under 6 weeks.
- Re-engineered Biorasi QMS, meeting European, Russian, and US regulatory requirements.
- Chaired Quality Review Board, Management Review, Complaint Response, and Design Transfer
- Converted in-house electronic records storage to Veeva systems.
- Converted paper diaries and CRFs to electronic eDiaries and eCRFs. 

 

**FISHER CLINICAL SERVICES**, Mt. Prospect, IL 2010 to 2012

**Director, Quality Assurance**

Directed Fisher Clinical Quality Assurance Department and provided assurance that GMP packaged investigational drug product and medical devices met required GCP and GMP requirements.

- Provided direction, leadership, mentoring, coaching, and training to QA/QC staff, meeting annual budget requirements and quality goals, as well as decreasing QA/QC staff turnover.
- Hosted ANVISA, DEA, EMA, EPA, FAA, FDA, ISO, MPA, State of Illinois, TUV, TSA, and WHO inspections, resulting in no observations requiring corrective action.
- Improved QA activities, including client QA liaison, clinical study reports, Deviation/CAPA Program, internal/supplier audits, KPIs/metrics/trends, Clinical Quality Council, training, internal investigations, investigator audits, IRB/EC audits, validation, and Vendor Management Program through re-engineering, efficiency gains, and effective delegation.
- Provided QA oversight for paper records to electronic records migration. 

 

**KV PHARMACEUTICAL**, St. Louis, MO 2007 to 2010

**Associate Director, Clinical Quality Assurance**

Established and oversaw first GCP Quality Assurance Department at KV and provided QA support to Clinical Operations, GMP Ops, Laboratories, Medical Affairs Pharmacovigilance, and Regulatory.

- Conducted risk-based GCP, GCLP, GMP, and GVP audits in Europe, North America, and Russia.
- Performed mock FDA GCP, GCLP, and GVP inspections, ensuring FDA readiness.
- Hosted first FDA GCP/GMP inspection of KV clinical trial at 4 St. Petersburg, Russia investigator sites (no FDA 483) and GMP facility, resulting in product registration 3 months later.

 

**EDUCATION**

**Master of Science (MS)**, Chemistry, University of South Dakota, Vermillion, SD

**Bachelor of Science (BS)**, Chemistry, University of South Dakota, Vermillion, SD

 

**PROFESSIONAL ASSOCIATIONS AND CERTIFICATIONS**

Society of Quality Assurance | ASQ Auditor | EU MDR Lead Auditor

ISO 9001 Lead Auditor | ISO 13485 Lead Auditor

[View full post](https://www.thefdagroup.com/find-consultants/031)

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