Quality Assurance Customer Service

Evtimia Dimitrova, PhD

347-***-**** ? ***.*********@*****.*** ? 303 West 66th Street, Apt. 12 CE ?

New York, NY 10023

quality assurance manager

Resourceful & Astute Leader with global background in GCP, GLP, PV, and GMP

auditing and record of success driving quality and compliance with FDA, ICH-

GCP, and international standards for clinical trials.

Offers expertise in developing, implementing, and managing Quality

Management Systems (QMS).

Leverages strong scientific background and expertise in all aspects of

quality clinical research from design, monitoring, and reporting of

clinical trials through introducing new products on the market.

Excels at creating SOPs, enhancing processes, educating staff, and driving

efficient workflow to ensure operational excellence and continuous

alignment with changing guidelines and global regulations.

Applies planning and analytical capabilities to lead multiple projects

simultaneously and resolve issues.

Adept at global relations, customer service, and coordination among

internal/external groups.

Overview of Key Strengths:

GCP Quality Assurance Due Diligence

Clinical Trial Conduct

GCP, GLP, PV audits Regulatory

compliance Training & Team Management

Site/Vendor/Internal Audits

Research and Development Expert Communication

Career History

Forest Laboratories Jersey City, NJ 2011-2014

R&D QUALITY ASSURANCE MANAGER

Enhanced the quality of outsourced clinical trial activities by rolling out

and managing an effective CRO/vendor QA program as well as coordinating and

leading more than 40 vendor audits. Analyzed vendor/CRO risks to improve

sponsor oversight.

Allocated resources for vendor audits and communicated findings across the

organization.

Organized and facilitated vendor, internal and site audits.

Instrumental in internal/partner PV audits.

Contributed to due diligence activities in support of in-licensing efforts.

Reported and followed up on audit observations and Corrective and

Preventative Actions (CAPAs).

Provided regulatory inspection support internally and externally to

vendors, and sites.

Delivered overall ICH-GCP training to foster compliance and process

improvement

Frontage Labs Hackensack, NJ 2010-2011

DIRECTOR OF CLINICAL QUALITY ASSURANCE

Created an effective QMS and SOPs for phase I clinical trials in accordance

with new GCP requirements.

Prepared internal and site audit plans, reviewed reports, and analyzed

trends in observations.

Hosted sponsor audits.

Trained staff members on requirements of new company SOPs.

Clintec International New York, NY 2010

SENIOR QUALITY ASSURANCE AUDITOR

Oversaw clinical QA compliance for newly launched US branch and developed

QMS and local SOPs.

Implemented CAPA plan, root cause analysis, and metrics to assess QMS non-

conformances.

Facilitated site and document audits.

Pierre Fabre Paris, France 2007-2009

CLINICAL QUALITY ASSURANCE MANAGER

Acted as the lead auditor of pharmaceutical company's oncology department,

ensuring overall project quality and clinical data compliance with ICH-GCP

requirements.

Developed QMS, SOPs, global risk assessment process, and CAPA in clinical

trials.

Functioned as the primary contact for regulatory inspections internally and

on-site.

Executed site/vendor audits and due diligence activities.

Delivered ICH-GCP guidance and training.

Provided oversight of CQA trainee auditors.

ICON Clinical Research Paris, France 2001-2007

QUALITY ASSURANCE MANAGER (2005-2007)

Collaborated with upper management in establishing QMS and quality metrics

for the French office. Led the development and execution of the annual

internal audit plan domestically and internationally.

Coordinated daily activities between QA and clinical staff.

Oversaw and organized auditors in France and Canada; ensured the team

operated effectively.

Supervised and organized audit resources and ensured the team operated

effectively.

Developed training programs on QA/audit standards and international

regulatory requirements.

Contributed to the team's professional development.

SENIOR QUALITY ASSURANCE AUDITOR (2001-2005)

Conducted investigational site and vendor/supplier audits in more than 30

countries worldwide.

Prepared audit reports as well as handled audit closure and non-compliance

follow-up.

Hosted client audits and regulatory inspections, including ISO 9001-2000

accreditation.

CLINICAL RESEARCH ASSOCIATE (1998-2000)

Contributed to regulatory/IRB submission activities in 10+ European

countries.

Monitored clinical trials in oncology, neurology, and infectious diseases.

Earlier Experience:

POST-DOCTORAL FELLOW

Laboratory of Immunobiology & Immunohaematology, Faculty of Medicine

Limoges, France

Associate Professor

Department of Immunology, National Center of Infectious Diseases Sofia,

Bulgaria

Research Fellow

Bulgarian Academy of Science, Institute of Biology & Immunology of

Reproduction Sofia, Bulgaria

Education and Professional Development

Post-Graduate Diploma - Clinical Immunology, Medical Academy, Sofia,

Bulgaria

Ph.D. - Immunology, Medical Academy, Sofia, Bulgaria

Master of Molecular Biology, University of Sofia, Bulgaria

Technology

Microsoft Office (Word, Excel, PowerPoint, Access, Outlook), Clinical

System Tracking

Languages

Multilingual: Native Bulgarian; Fluent English, French, and Russian

Contact this candidate