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Wanda Barr has over 20 years of experience in Operations and Quality Systems management, specializing in successfully improving targeted performance metrics while maintaining or reducing costs and maintaining compliancePrior to joining Hewlett-Packard she served as the Director of Operations, QA/RA for YSI Life Sciences bio-analytics group serving the biotechnology, medical device, food and beverage and pharmaceutical markets. Before joining YSI, Ms. Barr served in various Quality and Operations Management roles for Ferno-Washington, Inc.As an expert in her field, she holds many certifications in the Quality Sciences and Process Improvement areas, including a 6 Sigma Blackbelt and ITIL Practitioner: Change, Configuration & Release Mgt. Her educational background includes a Master’s Degree in Business from Xavier University which gives her a well balanced perspective between Quality System design and Business & Operations requirements.Barr is a member of the American Society for Quality and has supported the Cincinnati Chapter by serving for five years as the Program Coordinator and primary instructor for the Certified Quality Technician Program and as the primary instructor for Statistics/Reliability for the Certified Quality Engineer Program. She earned her bachelors degree in Business from Wilmington College and her MBA from Xavier University.Specialties: Quality Systems; Design & Implementation, Process Improvement; Lean Six Sigma DMAIC Methodology, Total Customer Experience, ITIL Service Management, FDA Regulation; Medical Devices & Pharmaceuticals
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Senior Director Quality AssuranceFerno Ems Apr 2023 - PresentWilmington, Ohio, Us -
Senior Director, Quality Assurance & ComplianceAdvarra Aug 2021 - Mar 2023Columbia, Maryland, Us -
Senior Director, Quality Assurance & Regulatory AffairsLuminex Home Décor & Fragrance Jan 2018 - Aug 2021
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ConsultantMaryville Technologies Feb 2012 - Dec 2017Consultant; Process Improvement, Six Sigma Blackbelt using Lean Sigma, DMAIC and DMADV methodologies, Service and Manufacturing environments, IT Service Management;Keynote speaker - Lean 6 Sigma – FUSION 2013 International Conference
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Account Business Manager, Oil & Energy Client (Bp Account)Hewlett-Packard Apr 2011 - Sep 2011Houston, Texas, UsAccountable for Account Business Management functions including Commercial Contract Management, Asset Management, Service Request Management and Financial Account Mgmt. The ABMgr also acts as a chief advisor to the Account Executive on the business and commercial strategy. Single point of accountability for delivery of all ABM functions to the Account. -
Quality & Regulatory Officer, Pharmaceutical (Pfizer Account)Hewlett-Packard May 2007 - Mar 2011Houston, Texas, UsHP Quality & Regulatory Compliance Leader including global oversight for quality of ServicesResponsible for Cross-tower Quality & Continuous Improvement for all regions. Key contributor to Transition and Transformation of Services resulting from acquisitions & organic growthResponsible for ensuring HP Quality and Compliance program meets Customer requirements as defined and agreedLeader for Continuous Improvement within each Service area to ensure the Services improve over the life of the engagementHP leader responsible for Quality and Service Level Management of PPM (Policy & Procedure Manual)HP Leader and SME for 6 Sigma initiatives and supportResponsible for overall program and direction setting of Delivery Excellence Quality team to ensure alignment to requirements including but not limited to root cause analysis and corrective/preventive action, Customer Satisfaction improvement, etc.
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Quality Systems & Solutions Leader (Pursuit Solution Architect)Hewlett-Packard 2005 - 2007Houston, Texas, UsWW Quality & Regulatory Competency Tower Lead for pre-sales 'Delivery Approval Process' - Quality/Regulatory; solution design, staffing models, and costing to ensure delivery readiness - Partnered with Service Delivery Tower solution architects to ensure technical solutions met Customer requirements - Approved Quality & Regulatory cross-tower solutions - Pursuit Team trainer to ensure understanding of regulatory impact for the Customer in IT Outsourcing engagements- Developed Quality Systems, Process Improvement, and Regulatory Compliance IT solutions for many global HP clients- Provided leadership, consultation, mentoring and subject matter expertise to account team Quality Mgrs. - Led 'Global Delivery Quality Framework and ITIL Process Metrics Plan' in support of global methods standardization initiative. - ITIL/ITSM process team in project to drive alignment of ITIL Process Goals to CSFs (Critical Success Factors) to KPIs (Key Performance Indicators) to Metrics/Measures (definitions and source). This enabled “standard” global best practice and consistent reporting across accounts and alignment to HP Services Executive Dashboard.
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Quality & Compliance Leader, P&G AccountHewlett-Packard 2003 - 2005Houston, Texas, Us$3B IT Outsourcing AgreementHP Quality & Regulatory Compliance Leader for P&G Account - Transition/Steady-State - responsible for ensuring HP Quality and Compliance program met customer requirements - Responsible for recruiting, direction setting, management, training/development and budget of the Quality Assurance staff. - Developed/implemented global staffing model for extended Quality team; recruited/trained staff from within technical delivery towers/sites to create a network of QA liasons to augment Account Quality team - Developed a compliance gap-assessment plan identifying key areas for improvement against baseline measure of 39% compliance for specific targets. Achieved 100% compliance within 6 months against 12 month contract target. - Developed/delivered Basic Quality & Compliance training to 2000+ employees within 6 months of contract. Achieved 100% compliance. - Developed/implemented an IT Compliance Scorecard within 6 months of contract - Standardized HP documentation templates for IQ/OQ/QR SOPs, etc. to provide consistent format/approach to regulated "quality" documents - Created a centralized document repository to support verification/qualification/validation records - Responsible for Policy Procedure Manual - Led a project to customize the SD tool to enable identification and tracking of regulated vs non-regulated CIs to enable separate process controls within the workstreams. - HP Audit Lead for FDA based audit for P&G Pharma at 4 sites on 3 continents that led to no significant findings related to HP Service Delivery - Prepared and delivered annual HP IT Outsourcing Quality & Regulatory Status Report to WW P&G Regulatory Officers & other key management personnel - Provided leadership & subject matter expertise for process improvement initiatives using 6 sigma DMAIC methodology.
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Director Operations, Qa/RaYsi Apr 2000 - Oct 2002Yellow Springs, Oh, UsLifeSciences Division, Medical Devices & Biotechnology Products(Blood/Glucose Analyzers, etc.)Management responsibility for Operations: Manufacturing, Procurement, Production Scheduling, Shipping/Receiving, and Quality Assurance & Regulatory Compliance functions. Budgetary Responsibility - Exceeded 100% of the Operational Performance Goals 2 years runningKey Measures: On-Time Delivery, Gross Margin, Productivity, Quality Costs - R&D Project Team Leader – Assumed leadership role when primary project failed proof-of-claims prior to production release. Led cross-functional team to confirm customer requirements, redefine project and establish new delivery date. Project delivered on time, under budget, met POC requirements. -
Manufacturing ManagerFerno Washington 1998 - 2000Wilmington, Ohio, UsManagement responsibility for fabrication/manufacturing operations (150+ employees, 6 supervisors) Budgetary Responsibilities. - Leader for transformation from a traditional manufacturing environment to cellularization through continuous flow and Kaizen methodologies. During this period, cellularization activities achieved a 40% productivity improvement with product cost reductions. On-time delivery increased by 35% while manufacturing overtime was eliminated. Manufacturing headcount was reduced by 10%. Revenue remained constant. - Leader responsible for development/implementation of a set-up reduction program that reduced fabrication set-up costs by 42% from prior fiscal year baseline standards. - Leader responsible for development/implementation of a CAPA program to support waste reduction and quality improvement initiatives in the fabrication process that resulted in 49% scrap reduction.
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Qa/Ra ManagerFerno Washington 1988 - 1998Wilmington, Ohio, UsResponsible for QA/RA program, including direction setting, management, and training of 13 member staff. Budgetary Responsibilities, - Responsible for domestic/international complaint handling process including review, Medical Device Report submissions, trending, and CAPA. FDA submissions inc. baseline reporting, etc. - Leader of the Quality System Audit team. - Led the Quality System conversion to FDA cGMP for Medical Devices (ISO 9001 based harmonized Quality System Regulation. System was audited 7 months after implementation with “no significant findings.” Conducted training for 500+ employees on FDA’s QSR - Project Leader responsible design/implementation of a Process Capability process to be used by the design/manufacturing engineers for process validation. - Project Leader for the design/implementation of electronic Supplier Rating program. System numerically assigns values to supplier as it monitors their performance of delivery schedule, product quality, and PO requirements. Trending capabilities.
Wanda K Barr Skills
Wanda K Barr Education Details
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Xavier UniversityManagement And Operations -
Wilmington CollegeBusiness
Frequently Asked Questions about Wanda K Barr
What company does Wanda K Barr work for?
Wanda K Barr works for Ferno Ems
What is Wanda K Barr's role at the current company?
Wanda K Barr's current role is Senior Director, Quality Assurance.
What is Wanda K Barr's email address?
Wanda K Barr's email address is wa****@****ink.net
What is Wanda K Barr's direct phone number?
Wanda K Barr's direct phone number is +193778*****
What schools did Wanda K Barr attend?
Wanda K Barr attended Xavier University, Wilmington College.
What skills is Wanda K Barr known for?
Wanda K Barr has skills like Process Improvement, Business Process Improvement, Six Sigma, Cross Functional Team Leadership, Itil, It Service Management, Business Process, It Management, Management, Analysis, Outsourcing, Quality Assurance.
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