add photo
Katia
katiamallebranche@comcast.net
404-483-1466
Atlanta, GA 39901
Regional Quality Manager – Southeast Division
24 years experience W2
0
Recommendations
Average rating
108
Profile views
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
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