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Principal Consultant

Location:
Madison, Wisconsin, United States
Posted:
January 14, 2018

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Bryan Kelly

*** ********* ****

Madison, Wisconsin, USA 53704

*-608-***-****

ac307j@r.postjobfree.com

Employment Objectives

I am seeking a permanent, contract or temporary managerial role in any of the following areas:

Technical Sales Support, Business Analysis, Program Management, Quality Systems, Data Analysis & Presentation, and Core IT.

Willing to travel extensively, nationally or internationally (I hold legal working and residency rights in the UK, USA and the EU).

Summary of Qualifications and Experience

Experienced technical manager in the areas of -- initiating, defining, controlling, completing and supporting large enterprise projects and initiatives.

Core focus on more technical initiatives where there is significant ambiguity, poor scope definition and often highly matrixed and unclear lines of command and control within an organization.

Exceptional people skills with a focus on both authority by influence and direct line management. Excellent coach and mentor with skills aligned with people and skill development in technical settings. Global outlook having operated and lived through-out the USA, EU and Africa.

An expert at aligning business goals with solutions. Skilled in the application of numerous solution development life cycles that are scaled to the nature of both the project and organizational culture. An excellent communicator with world class presentation skills, I am very comfortable with large audiences, customers and senior management presentations.

Both business and technically focused, with a keen interest in challenging engineering, computer science and R&D initiatives.

Currently working with several Chinese organizations on developing ‘business cases’ for the utilization of small unmanned aircraft systems (sUAS) as defined under FAA regulations per 14 CFR, Part 107. Interested in commercial business scenarios for sUAS flight platforms and software in a variety of industries such as - agronomy, engineering, surveying, security, public safety and broad scientific image analysis.

Extensive legislative & regulatory background with a primary focus on compliance with: ICH Guidance, ISO Compliance, US 21 CFR (US Food & Drug Administration broadly) and key parts of US 14 CFR (US Federal Aviation Administration – part of the US Department of Transportation).

Core Skills

People Development

Team Management

Organizational Culture Change

Program Management

Data Analysis

Business Analysis

Formal Business Auditing

Presentation Skills

FDA Compliance Background

21 CFR (FDA, GMPs, Part 11)

Training & Education

Quality Assurance & Compliance

Quality Control Program Development

IT Linked Initiatives

ISO Certification and related auditable compliance projects

Technical Sales Support

Mentoring and Staff Development

Tools, Technologies and Processes

Solid Agile development background, expert with this approach and its impact on an organization’s culture and practices

Project Management Body of Knowledge (PMBOK) expertise, certified as a Project Manager, also PRINCE2 certified since 2014

Competent Business Analyst using the ‘Business Analysis Body of Knowledge’ (BABOK v3) as guidance

Very strong ITIL background, ISO 20,000 - ITIL certified since 2006

Solid background with IT Infrastructure – primarily Microsoft and Cisco technologies, certified as an IT Instructor, MCT, MCSE and CCNA

Exceptional scientific background in the medical device, pharmaceutical and pure research fields

Skilled with cloud based collaboration technologies, SharePoint, JIRA, Box, Enterprise Google Products

Very comfortable with virtual meeting technologies

Professional Experience

OTC Consulting Inc., 1997 to the Present

Based in Madison, Wisconsin, United States, operating globally

Managing Consultant & Owner

Independent Consultant working with numerous very high-profile clients both industry and governmental:

Areas of focus and exhibits:

Classic ‘Project Management Body of Knowledge’ (PMBOK) approaches to Project Management, and the PRINCE2 methodology per Axelos & the UK Government. Certified Project Manager

Tomotherapy Medical Devices, focused on numerous projects related to external beam oncology radio therapeutics, now the Accuray organization

Numerous US FDA linked projects related to the remediation activities following consent decree situations, FDA Warning Letter remediation and numerous FDA form 483 responses

Project aligned with Pharmaceuticals, Biotechnology, Chemical Industries, Clinical Trials, Biologics and core research under US GMP requirements

Business Analysis roles for organizations with a focus on requirements gathering, requirements elicitation and control. Agile adoption strategies for software development teams & organizations still trying to adopt and refine this iterative approach

Numerous projects completed as an advising consultant in mature Agile aligned environments, education, medical device, Big Data, IT infrastructure etc.

Skilled in the application of ‘Business Analysis Body of Knowledge’ (BABOK - IIBS) approaches - in eliciting business needs from stakeholders

Several sophisticated projects linked to aerial UAV photogrammetry, lidar and infra-red spectral mapping – primarily for US Government Agencies

Skills in business case development for various aerial spectrophotometric technologies and novel flight payloads

Classical data analysis and statistical skills, competent with SAS-JMP and Tableau as a comprehensive data analysis and presentation tool set

Broad scientific skill set, chemical engineering, physics, mathematics and core data analysis

A comprehensive list of projects and time lines is available upon request, please note several projects are or have been projects for certain governmental agencies and only the framework of the initiative is described for reasons of confidentiality and legally binding non-disclosure agreements with the US Government.

Education & Academic Awards

B.Sc. (Hons) in Physics and Biochemistry, The University of Lancaster, Lancaster, England

Continuing Skill Development & Certificate Programs

Regulatory Affairs Certified – RAC-US. Obtained 2008

Project Management, PRINCE2 Methodology. Obtained 2014

ITIL Certified by Axelos and the UK Government. Obtained 2006

Microsoft Certified Systems Engineer (MCSE), Microsoft. Obtained 2000

Microsoft Certified Trainer (MCT). Obtained 1997

Two-Year Program in ‘Theoretical Computer Science’. The University of Oxford, England. 2004

Cisco Certified Network and Design Associate. Obtained 2000

US FAA Certified sUAS Pilot (Part 107 Small Unmanned Aircraft Systems). Obtained 2017

Professional Certifications

Chartered Scientist (CSci) – United Kingdom Science Council. 2013

Fellow of the Royal Society of Chemistry (FRSC), Royal Society of Chemistry, London, England 2010

Publications

Macroeconomics I and II - text books designed for senior high school and first year college level students, written for The Edison School System and published by Quantum Scientific Publishing. Key themes in both texts focused on global interdependencies of a technology enabled global economy. 2008.



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