www.davidHHawley.com

© David H Hawley 2016

P r of i l e H i gh l ig h ts

Industry Knowledge:

Pharmaceutical

Medical Device

Quality and Regulatory

Compliance

IT Quality

Cloud Compliance

A ff i l i a t i o ns :

ISPE Member

PDA Associate Member

S er v i ce s D e l i ve re d

Common Business Systems

and Validation Consulting

Development of Quality

System and Standard

Operating Procedures

Business Process

Optimization

Project Management

Upgrade Assessment

ERP Implementation

Vendor Assessment

Infrastructure Qualification

IT Quality systems based on

ITIL/GAMP/COBIT/ICH

Professional Profile

David H Hawley Independent Regulatory Compliance and Computer Systems Validation Consultant. David Hawley, has over 30 years of experience in IT in the Life Sciences Industry, including 20+ years as part of the Pfizer group, and over 10 years heading Business & Decisions Life Sciences group in the USA and the UK.

His skills include Validation and Compliance, ERP systems, ITIL and IT Quality. Key project experience includes management, planning, and implementation of diverse IT and other projects in the Life Sciences Industry, particularly Computer System Validation from small systems to large implementations such as SAP, Oracle E-Business Suite, Microsoft AX and Epicor ERP systems.

A regular participant at ISPE events, has presented, written articles, provided peer review on articles and books and is an acknowledged expert in the area of Cloud Compliance. He was also a regular writer and presenter of Business & Decision’s Life Sciences Computer Systems Web seminar series, from 2009 to 2016 and the author of dozens of white papers and data sheets.

Specialized knowledge includes 21 CFR Parts, 11, 210, 211, 600 and 820, Annex 11, ISO2000/ITIL ISO 27000 series, ISO14385, HIPAA, SOX, GAMP®5 and the associated GAMP Good Practice Guides.

Experience & Expertise (examples)

Johnson and Johnson, World HQ, NJ USA Sep- Dec2015 Compliance of IaaS and PaaS Facilities provide by Amazon Web Services for GxP applications. Medicago, World HQ, NC, USA. May-Sep 2015 IT Quality management system based on ITIL ISO 9000 and GAMP. PM and Technical lead. IT Service management and auditing. WL Gore, World HQ, PA, USA. Jan-Jun 2015 IT Quality Management System, with ITSM based on ITIL ISO 9000 and GAMP. PM and Technical lead. Florida production Engineering, NC, USA. Jan 2014 Dec 2014 Validation PM of Cloud-based ERP system for Med Devices, Infrastructure Qualification. Plex ERP World HQ, MI, USA. Jun 2013 - present ERP delivered as SaaS, Validation and compliance system linking IT QMS of Plex and clients. Infrastructure Qualification. PM and Compliance consultant. American Red Cross, MD, USA. Apr-Sep 2012 Principal Consultant and PM on migration to regulated Data Center, improvement of compliance methodology. KCI/LifeCell, NJ, USA. Sep 201 – Jun 2013 Project Quality Management and Validation resource for Oracle E Business suite implementation. AAI Pharmaceuticals, NC, USA. Oct 2011- Jan 2012. ERP Project Management & process improvement of Microsoft AX in Pharma production environment. GEHC Medical Diagnostics, WI, USA Jul – Nov 2012 Project & Quality Management and Technical resource for Electronic Lab notebook. Ash Stevens, MI, USA May-Oct 2011 Project Manager and Validation Consultant for Epicor ERP System Validation

Maryland Department of Corrections. May-Nov 2016 (Non-Life Sciences) IT project Manager for Mi-Case system. B&D North America. 2008-2016 Internal Consultant to Qualified Data center. Develop all ITQA and TSM SOPs and practices. Internal Quality Auditor of Data Center. Aspen Pharma World HQ, Mauritius. Apr-Jul 2014 Software selection, Global ERP system for GxP applications. Stryker Instruments, MI, USA. Feb-Jun 2011 Technical Consultant and Validation of Axeda Software and Infrastructure Qualification, for automatic communication of medical devices via Software as a Service. IDEV Technologies, TX, USA. Dec 2010-Jun 2011 Process improvement consultant and Project Manager for Epicor ERP System Implementation Beijing Pharma, Beijing, China. Sep 2009-Jun 2010 Development of IT QMS for IT Infrastructure and Oracle EBS. Infrastructure Qualification. Concurrent business process improvements around handling and product traceability. Co project with subsidiaries of Beijing Pharma, B&D UK and B&D China. Hemarus Ltd, FL, USA. 2009 Development of the IT QMS and general business process improvement for a startup organization involved in blood collections and processing. Lean IS Compliance, B&D, PA, USA. 2008-2016 Development of B&D Lean IS compliance system, for measuring compliance and improving efficiency. Linvatec, FL, USA 2006-2009 Quality and Validation PM for Oracle - E Business suite

www.davidHHawley.com

© David H Hawley 2016

C a re er h is to r y

David Hawley was born close to

the Scottish/English border and

trained in Chemistry at the

University of Northumbria, UK.

After a period of laboratory and

Industrial Engineering work he

became a Production Manager

for Medical Devices and

Pharma products with GD

Searle, shortly before it was

purchased by Monsanto

Pharma, which was in turn

acquired by Pharmacia and

incorporated into Pfizer.

Having moved into IT he

occupied several senior roles

before joining Business &

Decision UK in 2004. He

transferred to B&D USA in 2006

and spent over 10 years as

head of Life Sciences consulting

in the USA, working on projects

worldwide, often as head of a

team.

O t he r In fo r m at io n

David Hawley is a published

playwright, with several full-

length and short plays having

been produced. He is also an

occasional actor.

He is also active in Motorsport

and currently series Chief

Marshal for the MotoAmerica

US Superbike championship.

Experience & Expertise (Continued)

GE Healthcare, Multiple projects USA and Europe. 2006-2008

Lead consultant on Compliance Legacy Remediation project. Provided leadership to client under consent decree in remediation of multiple business systems at sites in the US, Europe and Asia. Supervised and provided direct support to 20+ consultants involved one or more projects, plus own projects. As Life Sciences Director provide strategic and technical consulting support to:

Oracle E-Business Suite implementation 2 instances in separate divisions of GE,

Oracle Agile PLM, PeopleSoft, Siebel

GEHC Regulated Customer Portal Web site.

Development of GE IT Quality Management System.

Infrastructure. Qualification

Write and present GEHC global validation training program in USA and UK.

Smith & Nephew, Wound Management, FL, USA & International sites 2006-7 Assess multiple Business systems for cGMP compliance and process improvement, for 21CFR Pt. 11. Develop IT Quality Management System for software and infrastructure.

Smith & Nephew Orthopedics, Memphis TN, USA. 2006-7 Validation of SAP. BW, WF, MM, AM, QM, PP Validation Project Manager. Responsibility for the validation of all aspects of SAP R/3 Implementation, Assist with development of business practices to SAP recommended methodology.

Smith & Nephew, Wound Management Division, Hull, UK. 2006 Lead consultant. Provided functional leadership to the client in determining best IT Quality practices for multiple business processes against GAMP® and Good Practice Guides, Dales Pharmaceuticals, Yorkshire United Kingdom. 2006 Assessment of IT infrastructure. Perform compliance gap assessment and report

Wyeth Pharmaceuticals Maidenhead UK, various European sites. 2004-5

Validation of Document management system based on Documentum. Write and present validation training, in UK, Switzerland, Hungary, Ireland and Italy Pfizer, Morpeth UK. 200-2004 Technical and business process team leader responsible for the redesign of the business process, upgrade and validation of software for an Apple-Mac based labeling and patient information leaflet design system. Pharmacia, Uppsala, Sweden and Brussels Belgium. 2001 Standardized application delivery by repackaging. Team leader and technical authority on the introduction of repackaging of compliant application software for “one click” installation to users’ desktop computers. Monsanto Life Sciences/Pharmacia, in St Louis, Chicago and Puerto Rico, USA, with US and EMEA coverage. 1996-2000 Internal SAP Consultant. Business process redesign, SAP System design, Installation and Validation. Member of a team (Materials Management, Production Planning, Work Flow, Warehouse Management and Quality Management Modules)

Qualifications Northumbria University UK: Chemistry - Bachelors Open University UK: IT/Mathematics – IT/Mathematics Northumbria University UK – Management Services. Postgraduate Diploma Vocational Qualifications include: PRINCE2 Project management Various certifications from Microsoft etc.

Contact Information

www.davidhhawley.com

david.h.hawley@gmail.com

https://www.linkedin.com/in/davidhhawley

https://twitter.com/davidhhawley

+1 314 809 1442

Address

12501 Trammell Ct

Creve Coeur, MO, USA