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.
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