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Computer System Validation Consultant

Malvern, PA, 19355
March 26, 2019

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Thomas Quinn * Oak Hill Circle

Malvern, PA 19355

610-***-**** (cell)

© 2019 The Hollis Group, Inc.

Career Goal Full time or contract position as a Senior Software Validation / Compliance / IT Manager, Consultant, or Engineer, responsible for Project / Master Plans, Execution, and Compliance. Computer Systems Verification, Validation, and Qualification (VV&Q) of Life Science Manufacturing / QA / Logistics, and Clinical Systems in a regulated environment.

Summary Senior Consultant – Computer systems compliance, operations, and infrastructure for a consulting practice serving startup / scale-up pharmaceutical, biotech, medical device manufacturing and clinical trial companies. Security and Privacy Director / Practitioner (CISSP). Skills • Requirements identification through installation / qualification of large- scale, computer-assisted, production and clinical manufacturing, QA, and logistics systems

• Software and Systems project management, development, verification, validation, and qualification (VV&Q) of human safety grade, FDA regulated-industry, information systems

• Experience in creating, executing, and auditing Privacy, Compliance, Quality, and Risk Assessment Policies, Programs, and Standards under US and EU Life Science Regulations:

o FDA 21 CFR, Parts 210, 211 - Drug cGMP’s

o FDA 21 CFR, Parts 820, 821 - Device cGMP’s

o FDA 21 CFR, Part 11 Electronic Signatures, Electronic Records o FDA Drug Quality & Security Act (DQSA), Drug Supply Chain Security Act (DSCSA)

o EU General Data Protection Regulation (GDPR), EU Annex 11, HIPPA: Pl. 104-191, HITECH: pl. Public Law 111-5, Title XIII,

• Risk, Liability, and Impact Analysis of the above regulations and operational systems

• Computer and network infrastructure VV&Q and INFOSEC

• Training development and execution of the above regulations and operational systems

• Board member, Committee Chair, Program Track Lead, and Speaker for scientific society, and industry group symposia and conferences Page 2 of 3

Thomas Quinn Resume’

© 2019 The Hollis Group, Inc.



Present –

Nov 1992

The Hollis Group, Inc. Paoli, PA

Senior Consultant IT Compliance Consultancy

• Prepares business plans, including marketing, sales, operating, and product development sections. Prepares grant applications and research reports for document management projects.

• Consults with IT project teams in Systems and Software Engineering

(S&SE) in Life Science Manufacturing and Clinical projects.

• Specializes in Operations and Logistics in Pharmaceutical, Biotech, Medical Device, and Healthcare sectors.

• Delivers consulting and audit services in INFOSEC, application validation, infrastructure qualification, privacy, risk assessment and management, and regulatory compliance.

• Writes and /or approves regulatory documentation.

• Conducts audits of projects, vendors, and government agencies.

• Recent experience with clinical logistics systems.

• Maintains CISSP security officer certification. Conducts investigations, training, and forensic evidence recoveries. Work


Nov 1992 –

Dec 1987

Digital Equipment Corp. Malvern, PA

Manufacturing IT Consultant Process Industry Segment

• Pre-Sales and Marketing: Designed strategies and programs, developed and presented corporate training programs, hosted industry symposia and trade show events.

• Managed and delivered consulting engagements to pharmaceutical and specialty chemical manufacturing companies.

• Performed business analyses and developed financial justifications for information systems investments.

• Designed computer system architecture, including hardware and software configurations, to support manufacturing operations.

• Specific experience with supply chain management (ERP / MRP), maintenance management, manufacturing execution, electronic batch record, product data and document management systems. Page 3 of 3

Thomas Quinn Resume’

© 2019 The Hollis Group, Inc.

Nov 1987 –

Dec 1984

Smith’s Industries Aerospace, Inc. Malvern, PA

Software Engineer Aircraft Instrument Manufacturer

• Specified, designed, developed, documented, and tested commercial passenger aircraft instrumentation systems software.

• Worked as the project technical lead on numerous real-time, embedded, flight-critical software projects.

• Served as documentation control engineer on multiple projects.

• Assisted with the development of software development, problem reporting, and documentation systems for FAA regulated projects. Dec 1984 –

May 1976

CertainTeed Corp. Blue Bell, PA

Product Development Engineer Building Products Manufacturer

• Research and development of manufacturing processes and quality assurance systems design for continuous fiberglass and chemical production facilities.

• Extensive plant start-up work, including line and team supervision of production facilities during proof-of-process phases. Education /


B.A., Physics LaSalle University

1981 Philadelphia, PA

• DEC Pre-Sales Technical Support curriculum (80 Hours)

• DEC transaction processing expert curriculum (40 hrs.).

• DEC software project management curriculum (40 hrs.).

• University of Pennsylvania Project Management Program (40 hrs.).

• Level II Commercial Board Neutral, American Arbitration Association.

(Mass claims / insurance industry / curriculum - 40 hrs.)

• Certified Information Systems Security Professional (CISSP), Safe and Secure Online ® Children’s Online Safety Instructor Grants &


Innovation Award, 1993-94 Ben Franklin Partnership Program, Commonwealth of Pennsylvania, "Affordable Document System Prototype”

Projects &


Specific Project(s) detail(s) and Work References are available upon request.

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