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Director of Quality & Regulatory Resume Example

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DIRECTOR OF QUALITY & REGULATORY
Summary

Highly accomplished, versatile Transportation Expert with extensive background supporting U.S. military operations, including logistics, supply chain management and training of high-impact teams within everchanging environments. Dynamic leader,consistently achieves outstanding results while building and maintaining strong, loyal relations with both clients and colleagues. Moves and relates effortlessly across all levels of management.

Skills
  • Strategic Quality Planning and Assurance
  • Lean Six Sigma Facilitation and Training
  • Vendor and Supplier Management
  • Compliance Management
  • GAMP Systems Expert
  • Knowledge of Auditing Systems
  • Relationship Building
  • Cost Reduction
  • Food and Safety Protocol
  • Team Training
  • ISO 13485:
  • 2016-Lead Auditor
  • ISO 9001:2015- Trained Internal Auditor Core Competencies
  • Lean Six Sigma Black Belt Certification
  • Lean Foundations Certification
  • Good Pharmacovigilance Practice Certification .
  • Auditing, Safety
  • Business processes, Sales development
  • CA, Six Sigma
  • Cost Reduction, SOP
  • Clients, Strategic
  • Client, Validation
  • Delivery, Vision
  • Product development
  • Drivers
  • GAMP
  • Human Resources
  • ISO
  • ISO 9001
  • Meetings
  • Personnel
  • Policies
  • Processes
  • Quality
  • Quality Assurance
  • Quality Control
  • Quality Management
  • Relationship Building
  • Retail
  • Risk Assessment
Experience
Affairs North America / Scapa Tapes North America, LLC | Knoxville, TNDirector of Quality & Regulatory02/2019 - Current
  • Updated financial, customer and business records with accurate information each day, preventing data loss and keeping files current.
  • Handled requests-for-information, delegating tasks to appropriate employee to optimize customer service.
  • Verified operation of office equipment by completing preventive maintenance requirements and calling for repairs.
  • Drafted meeting agendas, supplied advance materials and executed follow-up for meetings and team conferences.
Scapa Tapes North America, LLC | Knoxville, TNQuality Assurance Manager04/2015 - 02/2019
  • Oversaw quality operations and activities for the Quality Control Team, Quality Specialist and Quality Engineers across two manufacturing sites (Knoxville, TN and Inglewood, CA).
  • Established and deployed Product Life Cycle Management Program across 5 USA sites; led Risk Assessment meetings, performed internal/external audits and prepared PPAP documents during the product development cycle.
  • Successfully reduced yearly number of non-conformances by 75% by focusing on cGMP, GDP and SOP process alignment.
  • Conducted monthly business reviews with customers to identify and address concerns; resulted in a 34% increase in client retention and improved business relationships with clients.
  • Collaborated with engineering team to conduct PFMEA (Process Failure Mode Effect Analysis) meetings and identify “RISK” Drivers”; reduced regulatory violations by 29%.
Tate & Lyle, DEMONSTRATED ACHIEVEMENTS | Loudon, TNQuality Assurance Manager07/2005 - 04/2015
  • Led defect reduction project resulting in a cost savings of $200K annually based on reducing the top waste by 30%.
  • Achieved ISO 9001:2015 and ISO 13485:2016 certification following transition to new standards.
  • Reduced substandard suppliers and decreased incoming rejects by 90%.
  • Drove product and raw material reduction by 40% resulting in $500K savings, Managed a team of twenty Quality Control Staff for seven day, three shift manufacturing process for HFCS sweeteners, maltodextrin, ethanol and animal nutrition products.
  • Conducted internal, third party, FDA, USDA, Kosher and HALAL audits to maintain highest standard of Food Safety, Food Quality and Food Security.
  • Evaluated facility systems to ensure compliance with corporate/facility GMPs, GFSI (Global Food Safety Initiative) requirements, HACCP, sanitation and pest control procedures and corrective action programs.
  • Led plant manufacturing investigations utilizing 5 Why/Fishbone techniques to respond to all customer complaints and inquiries; improved customer complaint response cycle time by 70%.
  • Developed HAACP (Hazard Analysis Critical Control) program that consistently met GMA-SAFE, British Retail Consortium (BRC), Kosher, HALAL and third party audit requirements.
Education and Training
University of Michigan | Flint, MIB.S in Chemistry
Certifications
  • Strategic Quality Planning and Assurance
  • Lean Six Sigma Facilitation and Training
  • Vendor and Supplier Management
  • Compliance Management
  • GAMP Systems Expert
  • Knowledge of Auditing Systems
  • Relationship Building
  • Cost Reduction
  • Food and Safety Protocol
  • Team Training, ISO 13485:2016-Trained Internal Auditor, 2016-Lead Auditor
  • ISO 9001:2015- Trained Internal Auditor Core Competencies
  • Lean Six Sigma Black Belt Certification
  • Lean Foundations Certification
  • Good Pharmacovigilance Practice Certification .
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Resume Overview

Companies Worked For:

  • Affairs North America / Scapa Tapes North America, LLC
  • Scapa Tapes North America, LLC
  • Tate & Lyle, DEMONSTRATED ACHIEVEMENTS

School Attended

  • University of Michigan

Job Titles Held:

  • Director of Quality & Regulatory
  • Quality Assurance Manager

Degrees

  • B.S in Chemistry

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