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Katia
katiamallebranche@comcast.net
404-483-1466
Atlanta, GA 39901
Director, Quality
22 years experience W2
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Average rating
40
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Summary

Qualified and highly-trained professional leader with outstanding aptitude to direct and approve activities in the areas of development, compliance and operations complemented with strong communication skills, drive, and vision to inculcate a quality cGMP culture throughout the organization. Solid track record of producing world class quality in a highly regulated industry

  • Proven ability to effectively lead operations in a FDA accredited facility ensuring organizational objectives and voice of customer within established timelines and budgetary goals
  • Efficiently handle large-scale issues and concerns; analyze root cause and administer responsive PMQA management programs
  • Capable of high volume data analysis with demonstrated ability to effectively manage multiple projects simultaneously
  • Able to identify the strengths and weaknesses of colleagues and guide them in utilizing their potential toward success
  • Experience in laboratory setting including experimental design, statistical data analysis, hypothesis testing, and validation of laboratory equipment, assays, reagents, techniques, and SOPs.
  • Ability to work with internal and external clients to simplify complex business issues and enhance productivity.
  • Driven, dedicated and intelligent solution provider supported by strong academic training in Human Resource Management.
  • Competitively selected for the American Red Cross Biomedical Leadership Development Program (BLDP)

KEY STRENGTHS

  • Matrix Management
  • Problem Solving Methodology
  • Statistical Data Analysis
  • Auditing
  • CAPA Management
  • Total Quality Management
  • Equipment/Process Validations
  • Continuous Quality Improvement
  • Product Complaints Management
  • Document Control System
  • Value-Added Processes
  • Strong Communication Skills
  • Keen Attention to Detail
  • Leadership and Team Building

SELECTED CAREER HIGHLIGHTS

  • Active role in the structural reorganization of the American Red Cross from geographically based model to a model based on functionalized systems.
  • Recruited for the American Red Cross Biomedical Leadership Development Program 2015
  • Assisted in the development of a root cause analysis tool specific for the implementation of a nation-wide data management system
  • Spearheaded a culture change to one focused on world class quality which resulted in significantly increased compliance.
  • Streamlined and improved operating procedures resulting in a 50% reduction in reportable events to FDA.
  • Implemented more effective scheduling of the ARC testing laboratory, which resulted to a 30% increase in production
  • Worked directly with the Chief Executive Officer in assessing regulatory compliance and developing strategies for improvement within the region.
  • Developed inter-departmental relationships through improved communications and by grooming staff to make key decisions and solve day to day problems.

Experience
Director, Quality
Information Technology
Jul 2016 - present
Douglasville, GA

Southern/Alabama & Central Gulf Coast/Tennessee Valley

Notable Contributions:

  • Standardized/consolidated quality assurance functions between three regional entities thereby increasing departmental efficiencies while ensuring processes continue to operate in a state of control with regulatory compliance as top priority
  • In partnership with executive operating officials, developed strategic quality planning to continuously improve compliance profile with focus on selected indicators

Project Management Quality Assurance
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Regional Quality Manager – Southeast Division
Information Technology
Dec 2015 - present
Atlanta, GA

Notable Contributions:

  • Direct supervision of 10 Center Managers
  • Accountable for all quality facets of the donor centers, ensuring that compliant, feasible and effective quality systems are maintained.
  • Provide input and suggestions for SOP revisions and improvements of quality systems and procedures
MS Visio
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Regional Quality Manager - Southeast Division
Dec 2015 - Jul 2016
Atlanta, GA
Notable Contributions:
  • Direct supervision of 10 Center Managers
  • Accountable for all quality facets of the donor centers, ensuring that compliant, feasible and effective quality systems are maintained.
  • Provide input and suggestions for SOP revisions and improvements of quality systems and procedures.
MS Visio
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Interim Director, Quality
Information Technology
Aug 2013 - Mar 2016
Douglasville, GA

Southern/Alabama & Central Gulf Coast/Puerto Rico Regions

Notable Contributions:

  • Standardized/consolidated quality assurance functions between three regional entities thereby increasing departmental efficiencies while ensuring processes continue to operate in a state of control with regulatory compliance as top priority
  • In partnership with executive operating officials, developed strategic quality planning to continuously improve compliance profile with focus on selected indicators
Project Management Quality Assurance
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Manager, Quality Assurance
Information Technology
Jan 2010 - Dec 2015
Douglasville, GA

Notable Contributions:

  • Developed teams to perform process improvement activities within the Quality Assurance department to standardized and streamline processes.
  • Worked collaboratively with Operations and Problem Management to perform high level investigations, identify root cause, and to develop and implement Corrective Action Plans to prevent recurrence of non-conforming activities.
  • Continuous standardization/stabilization efforts such as development of an intake process, re-evaluation of regulatory requirements to drive increased efficiency, and adherence to industry-standard problem solving methodologies
Quality Assurance Problem Management Process Improvement
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Quality Assurance Officer - Southern Region
Information Technology
Nov 2008 - Jan 2010
Douglasville, GA
Notable Contributions:
  • Responsible for problem solving, compiling quality metrics and developing compliance status reports for senior management and staff.
  • Active participant in the development of a root cause analysis tool used for the nation-wide implementation of new donor/inventory management software.
  • Developed/Implemented company-wide corrective actions to mitigate systemic risks.
  • HELD American Red Cross
Quality Assurance
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Sr. Quality Assurance Associate
Medical Devices
Feb 2008 - Nov 2008
Marietta, GA
Quality Assurance
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Sr. Research Associate
Information Technology
Nov 2000 - Jun 2005
Framingham, MA
No skills were added
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Process Engineer
Information Technology
Sep 1999 - Nov 2000
Framingham, MA

n/a

No skills were added
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Edit Skills
Non-cloudteam Skill
Education
Master's in Clinical Investigation
MGH Institute of Health Professions Boston
Bachelor's in Information Science
Johnson & Wales University
Biology
Lincoln University
Certifications
STAT A MATRIX (certified
Project Management Fundamentals
American Society for Quality - Quality Auditor: Certification #45704 (recertified
Skills
Quality Assurance
2021
12
Project Management
2021
6
Problem Management
2015
5
Process Improvement
2015
5
MS Visio
2021
4
Quality Management
0
1