Program/Project/Quality Manager

Senior Program/Project/Quality Manager with significant experience

delivering medium to high-risk/complexity projects in multiple industries

and environments, on-time and under budget. SME for project management

office development and technical scope analysis supporting business

requirements. Provide reliable financial estimates and reports, costing

estimates, budgeting, schedules, forecasts and assignment of resources on

projects ranging in size from $100k to $2mm each for 1 to 15 associates per

project. Hands-on application of PMBOK project management methodologies,

SDLC, federal and state regulatory requirements pertaining to projects and

industries served. Strong understanding of Six Sigma, Lean manufacturing,

Kaizen, Continuous Improvement and Management Change methodology.

Enterprise Experience

Program/Project/Quality Management

. Conducted a three month pilot project to evaluate and outline the

structure of a Project

Management Office (PMO) for potential new projects for the State of

Indiana, Childcare Services

. Responsible for Project Management for the Quality department at

Briljent, LLC. Developed a metrics tracking and forecasting program

that provided advanced notification to executive leadership of

products in danger of missing due dates

. Significant experience managing project timelines, resources, and

reporting using MS Project and other enterprise project management

tools. Experience defining, tracking, and driving technical and

business resources to meet timelines for deliverables, milestones, and

project completion

. Project Manager for 15 separate engagements totaling up to 50

resources with over $5.2 mil P&L responsibility for client supporting

software interface and report development, GxP validation, and testing

at various locations for Eli Lilly and Company

. Initiated and Implemented a PMO for CTG's Life Sciences Solutions

division utilizing PMBOK, CTG Project Management Methodologies, and

PMI principles. Ensured PMO office standards, policies, practices,

procedures, and documentation were in compliance with CTG ISO-9001

certification standards/requirements

. Experience managing, tracking, and reporting Estimated Cost at

Completion (ECAC) throughout project life and delivering project

within budget

. Audited supplier qualification to FDA 21CFR-11 regulatory requirements

for Roche Diagnostics

Training & Development

. Edited and proofread technical reports for new compounds ready to

submit to FDA. Created Style and Standards Guide and templates for

technical report writing for scientists and engineers

. Wrote training material and documentation for use by Medicare call

center representatives

. Reviewed numerous technical documents for quality, accuracy, content

and proper format

. Personally trained over 250 people and led process improvement teams to

save $2mil per year.

. Wrote training curricula on CPI, problem solving, team-building and

conducted training classes

. Taught quality improvement principles to all levels from front-line to

'C' level management

Software Development and Testing

. Created, wrote, and executed test protocols and scripts for new medical

software launches

. Led teams in requirements gathering, design, construction and

implementation phases of SDLC

Customer Relationships

. Personally developed new project proposals outlining scope of work and

cost/benefit analysis for $6.5mil of new business over a three year

period

. Identified resources, wrote and implemented Project Plans, and

maintained client satisfaction

. Continuously worked with customer base to inform, track, report, and

ensure quality delivery of project deliverables, milestones, or

completion

Education, Skills and Certifications

Education

Butler University, Indiana; Master in Business Administration (MBA):

15 of 33 credits

Purdue University; Indiana; Bachelor of Science in Industrial

Engineering: Deans List

Took PMP qualifying course covering PMI/PMBOK requirements. Utilized

PMBOK methods in PMO operations. In the process of applying to take

the PMP certification test.

Skills

MicroSoft: Project, Excel, Word, PowerPoint, SharePoint, Visio. PPM

software: AtTask, Clarizen, JIRA, ProChain, PeopleSoft, Oracle ERP,

Windows, SAP, ISO9000, Failure Analysis (FMEA), FDA (Part 21CFR-11),

Lean manufacturing, Kaizen, Six Sigma and SPC

Certifications Certified Change Master for corporate cultural change

initiatives

Life & Health Insurance License, State of Indiana through 12/2014

Professional Experience

10/2013 - Present Crew Corporation - contract engagement,

Indianapolis, IN

Senior Technical Writer - at Eli Lilly and Company

< Review, edit and proofread technical scientific reports for proper

format, grammar, spelling, word usage, structure, flow and overall

readability in preparation for readiness to submit to FDA for

approval.

< Created Style and Standards Guide and technical report templates.

< Assisted in training and instruction to scientists and engineers on

report writing requirements and structure for global locations.

6/2013 - 9/2013 Pyramid Technology Solutions - (3) month contract,

Indianapolis, IN

Project Management Office (PMO) Manager - for State of Indiana, DCS

< Evaluated PMO structural needs, set-up and established reporting

system, and reviewed corporate Governance requirements for future

projects.

< Contributed to transition plans to adapt new methodologies, wrote

and edited job descriptions for new PMs and QA audit staff.

9/2010 - 6/2013 Briljent, LLC, Indianapolis, IN

Project Manager / Quality Coordinator -

< Oversaw achievement of quality goals and initiatives, including

design and manufacturing process improvement for existing and new

products.

< Continuously monitored and improved programs for effectiveness.

< Analyzed training product content, process flows and quality

metrics.

Utilized AtTask project management software to initiate, plan,

implement and track daily project performance for the Quality

Department.

< Measured on-time product delivery performance which exceeded client

goal of 95% consistently at over 97% on-time for the last 13 months

of the contract.

< Worked closely with cross-functional representatives to identify and

resolve production and quality system deficiencies.

< Developed Corrective Action initiatives including evaluation of

failure investigation and corrective action plans, root cause

analysis and follow-up activities. Enabled rapid and effective

correction of quality problems in a manner that prevented their

reoccurrence.

< Provided guidance as subject matter expert on type of validation

required for appropriate applications and how to validate it.

Reviewed and approved product and process change control

documentation and specifications.

Instructional Designer -

< Created, wrote and reviewed technical training documents for

customer service representatives for Medicare in compliance with FDA

regulations.

2011 - 2012 Part-time Contract Consultant to Crew Corporation,

Indianapolis, IN

Senior Technical Writing Consultant - For Covance, Inc.

< Researched, compiled requirements, and wrote Standard Operating

Procedures, Qualification Guidelines and Maintenance Guidelines for

Chilled Water System.

Software Testing Consultant - For Praxis Management International, LLC

< Wrote and developed software validation Test Protocols, Test Scripts

and executed scripts for a new software launch.

2003 - 2009 Project Engagement Contracted Consultant; Indianapolis, IN

Project Manager - at Eli Lilly and Company

< Managed 15 different fixed price and time and material projects

ranging from application development and software implementation to

quality assurance, technical writing, and testing.

< Delivered projects on time and within budget

< Established new PMO for company Life Sciences Solutions division

< Managed up to 50 technical resources simultaneously

< Trained in company Project Management Methodology (ISO certified)

< Utilized MS Project, company tools, client tools, and self-developed

tools to manage and report on project status and progression

< Performed Supplier qualification audits to FDA 21 CFR Part 11

regulations

< Compiled, wrote, edited and executed GxP validation plans, test

plans, protocols and scripts

2000 - 2003 Independent Contractor to Multiple Companies in Indiana

Project Manager - at MerchantWired, Inc.

< Created Project Plan in MS Project, developed strategy, schedules,

tracking, and supervised project deployment while improving client

relationships.

Senior Project Manager - at Dorel Juvenile Group

< Improved forecasting, quality, procurement cycle, and reduced

variations while streamlining production and supply-chain processes.

< Led teams in reducing inventory levels 25% from $120mm to under

$90mm in four months.

Project Manager - at MerchantWired, Inc.

< Completed implementation of 580 retail sites ahead of schedule

utilizing MS Project and reestablished favorable relationship with

client senior management.

Senior Manager - at Cummins Engine Company

< QS9000 Subject Matter Expert for review, analysis and edit of

quality and production standard operating procedures and

documentation.

< Conducted process training and reviewed 200+ procedures in

preparation for Oracle ERP implementation for global client.

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