Ambitious and self-motivated seasoned Executive who creates and deploys strategies with organizational leaders to effectively align and drive key business initiatives and customer satisfaction. Proven track record of building and retaining high performance teams through hiring, development and motivation of direct reports and peers.
Certified Lead Management Systems Auditor
ABS Root Cause Analysis
Lean Six Sigma Green Belt
Hudson Leadership Development
Human Error Reduction
Power of Influence
Microsoft Office Suite
SAP QM Module
Statistical Process Control
Lean Tools & Methodologies
Train the Trainer
Adult Focused Training
Vice President, Quality06/2011 to CurrentEssentraGreensboro, NC
NOTE: Previously Clondalkin Pharma & Healthcare, Keller Crescent and Pharmagraphics
Manages/improves all facets of the quality management and training systems in compliance with cGMPs, PS 9000, ISO 9001 and customer requirements.
Responsible for the development, deployment, and effectiveness of Quality procedures and process training.
Owner of supplier and service providers' qualification and performance.
Customer contact for quality and service issues, and the continuous improvement thereof.
Through focused improvement projects, realized a reduction in customer complaints and Cost of Poor Quality of 10%.
Developed harmonized metrics system for quality performance and training effectiveness.
Implemented training matrices for skill assessments and continual advancement of employee knowledge.
Lead the organization to improve process flow, resulting in a 12% increase of on-time and in-full shipments to customers.
100% success rate of customer audits and ISO 9001, PS 9000 and SFI/FSC certifying audits.
Improved customer facing role requirements, increasing customer response time by 33%.
Director of Quality06/2006 to 06/2011Clondalkin Pharma & HealthcareGreensboro, NC
Note: Clondalkin Pharma & Healthcare was purchased by Essentra in 2015 and was branded as Clondalkin Pharma & Healthcare in 2011, previously Keller Crescent (2009 - 2011) & Pharmagraphics (prior to 2009).
Managed Quality budget & staff of QA Managers & teams at 9 sites specializing in secondary pharmaceutical & healthcare packaging.
Managed all facets of the quality management systems in compliance with cGMPs, PS 9000, ISO 9001 and customer requirements.
01/2006 to 01/2011
Led the company's Lean Manufacturing Program, training all sites on Lean Principles/Tools, leading Kaizen events and tracking and reporting of results to Senior Management
Created and implemented a Corporate Quality Management System, harmonizing 9 sites from 5 legacy companies.
Achieved corporate certification to ISO 9001:2008.
Achieved corporate certification to PS 9000:2011, a quality standard designed for manufacturers of packaging intended for medicinal products; becoming the first and only US Corporation to achieve certification.
Led an average of 15 kaizen events annually, including setting up Kanban systems, SMED, value stream mapping sessions and standard work events.
QA Manager10/2005 to 06/2006PharmagraphicsGreensboro, NC
Managed the Quality department budget and staff of site QA team.
Managed the site's Quality Management System including management reviews, complaints, root cause investigations, calibrations, documentation and change control, training and process validations and internal audits.
Hosted customer audits
Designed and implemented a process & equipment validation program.
Implemented a Supplier Quality Management Program.
Created a new quality metrics system to communicate the quality KPIs to senior management and site personnel.
Reduced quality complaints by 12% through improvement projects in QA and operations.
Improved QA review and release of finished goods process, increasing data accuracy and a reduction of 8 hour queue time.
01/1997 to 01/2005
Managed electronic quality systems including training end users, developing standard operating procedures and troubleshooting issues.
QA Systems Leader06/1994 to 10/2005Procter & GambleGreensboro, NC
01/1994 to 01/1997
Performed quality inspections of incoming packaging materials for compliance to specifications and pharmaceutical/medical device regulations.
Performed supplier audits and performance management.
Developed and executed validations for electronic quality systems.
Performed all job functions in compliance to 21 CFR 211 & 820.
Participated in FDA routine audits.
Executive Certificate in Business AdministrationMarch 2016University of Notre Dame, Mendoza College of Business
Small Business Administration2015Northern Arizona UniversitySmall Business Administration
Information Technology2001Patrick Henry Community CollegeInformation Technology