Manager Management

MICHAEL STEPHEN POWER

**** ******** ***, ********** ** 23805 703-***-**** ***********@*****.***

Profile:

Executive consulting and program / project manager with domestic and international program experience. Demonstrated ability to build high performing global teams with proven record of managing complex strategic programs exceeding $50MM. Effective at collaborating with divergent senior management and C-Level executives to achieve consensus and to manage change for client programs.

Consulting Experience / Skills:

Strategic PMO / Project Management

Consulting Business Development and Growth

Product Lifecycle Management (PLM)

Enterprise Resource Planning (ERP)

oExperience supporting financial systems, human resource systems, purchasing systems, warehousing, facilities management

Manufacturing Execution Systems (MES)

Quality Management Systems (QMS, Closed Loop Quality, DMS, LIMS)

ASRS / AGVS / Monorail Carrier Systems

Quality Assurance & Compliance

Organizational Change Management

oStake holder analysis, DFSS, VOC, communication, team education and training

Lean, Six Sigma Black belt

oValue Stream Charts, Work Breakdown Structures.

Management and Delivery of Strategic Roadmaps

Professional Experience:

RVR LLC, Founder, Principal Mar 2011 - Present

Client: Baxter International - Round Lake IL

PLM Strategic Program Manager Mar 2014-Jan 2017

Directed activity for a $32MM global PLM program to migrate a Team Center Enterprise PLM application to a Team Center Unified global PLM application addressing product definition for Fortune 100 manufacturer

Performed DFSS Stakeholder interviews and analysis

Managed change management and communication for program

5 work stream in program

Acted as SCRUM Master / Coach for engagement.

Taught client Agile SCRUM Methodology

Managed project with MS Project and JIRA

Johnson & Johnson - Bridgewater NJ

PMO - PLM Consulting Executive Apr 2013 – Jan 2014

Directed PMO assessment to develop roadmap and project plan to consolidate multiple vendor PLM applications into a single PLM instance for Fortune 100 global manufacturer.

Zimmer Holdings - Warsaw IN May 2012 – Feb 2013

Director PMO (PLM & MES)

Directed $20MM global program to configure and install SAP ME (MES) into a leading global manufacturer. (Full SAP Life Cycle with application development, testing, and commissioning)

Crafted approach for SAP ME (including EBR, recipe management, asset management, resource management)

Capgemini, – Jersey City NJ May 2011 – Feb 2012

Supply Chain Principal

Managed Quality Compliance for global practice addressing SAP consolidation for Fortune 20 manufacturer.

Established SAP based serialization / track and trace practice

oDefined and executed vendor alliances with serialization partners for track and trace and visions systems

Managed ASRS / AGVS; MES (Manufacturing Execution System) practice

Designed a program for a Fortune 50 Life Sciences manufacturer to achieve CSV (computer system validation) of applications developed using Agile Scrum methodology, producing estimated yearly cost savings of $1.5M.

Managed PMO for multiple strategic roadmaps outlining transformation of a Pharmaceutical and Biologics Company from clinical III completion into commercial manufacturing

Regulatory Compliance Associates, Inc., - Kenosha WI Mar 2010 – Mar 2011

Director

Provided quality compliance remediation and resolution for several domestic and international medical device and nutritional manufacturers.

Facilitated FDA preparation training, auditing, and computer system validation (CSV) for a consumer pharmaceutical provider.

Provided auditing and remediation resulting in extensive computer validation (CSV) for global medical device call center application

Provided auditing and computer system validation remediation for medical device manufacturing (multiple sites) in China

Provided auditing and computer system validation remediation (training, CSV, Master Validation Plan, and FDA audit preparation) for domestic (US) blood testing and management lab.

Cognizant - Teaneck NJ Oct 2008 – Feb 2010

Engagement Manager

Crafted and managed $12 MM Agile development program for an award winning, state of the art, client facing clinical investigator portal, resulting in client savings of $100M within 3 years.

oPerformed DFSS Stakeholder interviews and analysis

oDelivered Agile SCRUM methodology for program

oManaged organization change and communication for program.

oEducated company on approach for Agile SCRUM development. (coach / educator)

Managed Pharmaceutical PMO for $18M program addressing regulatory compliance of clinical data required for electronic data capture (EDC), submissions, adjudication, and clinical trials management

Guided analysis and requirements for a SharePoint based Document Management application (NextDocs) for a Fortune 50 global manufacturer

BearingPoint, Tyson’s Corner VA Mar 2006 – Sep 2008

Sr. Consulting Manager

Created technology roadmap, crafted solutions, and deployed QMS (Quality Management Solutions) and MES (Manufacturing Execution System) for startup manufacturer..

Assisted MES vendor in defining and implementing Shop Floor Optimization and MES, Closed Loop Quality into their commercial offering. (features included: EBR, Recipe management, asset management, resource management)

Deployed a global strategy for a European based global manufacturer to complete a regulatory and compliance assessment and validate a consolidation of global manufacturing SAP instances by region.

Managed deployment of Documentum DMS for consumer products manufacturer.

Managed definition and e-Pedigree pilot for product re-packager / wholesaler.

Entegreat, Inc., Birmingham AL Jan 2004 – Feb 2006

Program Manager

Defined consulting approach and roadmap for SAP Deployment, Packaging Optimization, MES (EBR, recipe management) for CPG manufacturer.

oManaged the configuration, engineering, validating, and deployment of SAP connectivity to aseptic fill/finish suite for an international CPG manufacturer.

Honeywell, Herndon VA Mar 1996 – Jan 2004

Senior Consultant

Managed and deployed multiple manufacturing execution system (MES) implementations for pharmaceutical, biologics, medical device, fine and specialty chemical, consumer pharmaceutical, medical nutritional, cosmetics, plastics, electronics, and consumer packaged goods manufacturers in the US and Europe.

oApplications included Recipe Manager, Weigh/Dispense, ERB, Asset Management, Deviations/Quality Management, Resource Management)

Crafted and managed development for “Next Gen’ MES application jointly developed with client company and vendor to manage biologics manufacturing for vaccine and biologic product facilities. ($6M project)

oActed as Agile SCRUM Master

oReceived Agile SCRUM certification.

Abbott Labs, Columbus OH May 1982 – Feb 1996

Special Program Manager

Directed regulatory assessment, installation, configuration, testing, computer system validation, disaster recovery, deployment, and end-user training for warehouse management systems WMS) and interfaces to ERP at 5 Abbott Nutritional plants.

Directed a team of 300 engineers, for the definition, funding, engineering, implementation, compliance, validation, and commissioning of three automated warehouse and distribution systems for a Fortune 10 pharmaceutical, biologics manufacturer. (P&L of $44MM)

Installed and commissioned $40MM automated material handling and distribution system in Columbus Abbott Nutritional plant.

Education and Certifications:

Bachelor’s Degree in Mechanical Engineering ~ Christian Brothers University

Project Management Professional (PMP) (Kepner - Tregoe) -- Grandfather to PMI

Six Sigma Black belt – Lean, TPS / Six Sigma Greenbelt

Certified Pharmaceutical GMP Professional (CPGP)

Professional Affiliations and Published Material and Speaking Engagements:

Member of the FDA’s 21CFR Part 11 committee.

Frequently speak (seminars and webcasts) and write (trade publications, white papers) on a number of compliance and manufacturing transformation subjects.

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