Stephen Ferrell

Stephen Ferrell Email and Phone Number

Chair GAMP Americas @ ISPE
Philadelphia, PA, US
Stephen Ferrell's Location
Greater Philadelphia, United States, United States
Stephen Ferrell's Contact Details

Stephen Ferrell personal email

About Stephen Ferrell

Mr. Ferrell is a recognized expert in Software Assurance, IT Governance and Cyber Security in multi industry disciplines but particularly in the Life and Health Sciences. He is currently Chief Strategy Officer at Strike Graph, a global Compliance Posture Management (CPM) platform provider.Mr. Ferrell is the co-Chair of GAMP Americas and a member of the ISPE GAMP Global Steering committee. Stephen was the project lead for the ISPE GAMP IT Infrastructure Control and Compliance Guide Rev2 and a contributing author to ISPE’s GAMP 5 2nd Edition.Mr. Ferrell was co-founder of CompliancePath Ltd, a Scottish and US Compliance services company that support’s regulated clients all around the world and in 2021 ultimately leading the company to be acquired by Ideagen in 2021.Mr. Ferrell has held executive, consultative and senior level management positions with a number of technology firms in the Life Sciences, represents the Scottish Life Sciences Association in the USA, and was a signatory on the historic ‘Turnpike Agreement’ which created collaborative channels for US & Scottish Life Sciences companies to share knowledge and expertise. Mr. Ferrell is a trusted advisor to the US FDA, having provided CSV, Cloud and Data Integrity training directly to the CSO's.Mr. Ferrell’s industry experience includes managing IT compliance processes to ensure adherence to applicable regulatory statutes, GDPR, Global GxP, FDA, MNPA, Health Canada, HIPAA/HITECH, FISMA, FedRAMP as well as financial and government regulations, and standards such as ISO 9001, EHNAC, ISO 27001, NIST 800:53, HITRUST, ITAR. Mr. Ferrell is a Certified Information Systems Auditor (CISA), and is Certified in Risk and Information Systems Control’s (CRISC).

Stephen Ferrell's Current Company Details
ISPE

Ispe

View
Chair GAMP Americas
Philadelphia, PA, US
Website:
ispe.org
Employees:
534
Stephen Ferrell Work Experience Details
  • Ispe
    Chair Gamp Americas
    Ispe
    Philadelphia, Pa, Us
  • Strike Graph
    Chief Strategy Officer
    Strike Graph May 2024 - Present
    Seattle, Wa, Us
    Helping customers accelerate their compliance journey and maintain a pragmatic, risk aware security posture.
  • Ispe
    Co-Chair Ispe Gamp Americas
    Ispe Oct 2023 - Present
    North Bethesda, Maryland, Us
    Serving as co-Chair of GAMP Americas alongside the brilliant Brandi Stockton and Levi Schenk.
  • New Zealand Trade And Enterprise
    Beachhead Advisor - Life Sciences (Nz Gov)
    New Zealand Trade And Enterprise Jan 2022 - Present
    Auckland, Nz
    As a Beachhead advisor, I work with NZTE to support NZ-based Life Science and Health Care centric software companies navigate their US commercial and regulatory strategies.
  • Compliancepath Limited - An Ideagen Company
    Vp It Governance & Software Assurance
    Compliancepath Limited - An Ideagen Company Jan 2014 - May 2024
    Glasgow, Gb
    Co-founder of CompliancePath. Grew company from local consultancy to global IT Governance & Life Science professional services provider. Acquired by Ideagen in 2021. GxP Cloud, IT Validation, Scotsourcing, Executive/Management Secondments, Software Commercialization. ISO27001, SOC2, PCI DSS, HIPAA, HITRUST, FedRAMP, StateRAMP.
  • Temple University School Of Pharmacy
    Adjunct Lecturer, Temple University, School Of Pharmacy, Ra/Qa Graduate Program
    Temple University School Of Pharmacy Nov 2020 - Jan 2022
    Philadelphia, Pennsylvania, Us
    Lecturing on IT Governance and Software Assurance in the Life Sciences.
  • Promedim
    Managing Partner -Product
    Promedim Oct 2014 - Nov 2021
    London, England, Gb
    Promedim is a Cloud enabled fully 21 CFR Part 11 compliant application architecture that supports Clinical Studies, Field Service, Medical Telepresence and SaMD support use cases.
  • Ruro, Inc.
    Vp Operations & Cco
    Ruro, Inc. Apr 2018 - Mar 2020
    Supporting the CEO & Board by providing leadership to the Engineering, PMO, Quality, HR and Marketing functions. Ensure that SaaS delivery of RURO product portfolio is compliant with US, EU, Chinese GxP and other Global Life & Health Science Regulatory Requirements.
  • Bytegrid
    Vice President, Product Strategy
    Bytegrid Oct 2017 - Apr 2018
    Silver Spring, Maryland, Us
    Supporting operations, sales, marketing and GRC with the expansion of our XaaS product portfolio and our compliance toolset. Aiding customers in the Health, Life Science, Fintech, Federal and State Government verticals with risk based regulatory transitions into the cloud.
  • Thermo Fisher Scientific
    Sr. Director, It Compliance
    Thermo Fisher Scientific Dec 2016 - Nov 2017
    Waltham, Ma, Us
    Responsible for partnering with the business and IT towards maintaining the GxP compliant state of our global software platforms.I oversee all aspects of the BioServices Division Computer System Validation and global IT Compliance activities that support cGMP processes for this division.Additionally my team partners with operations, corporate ITQA and other QA personnel in the development, implementation, project management, release, periodic review and maintenance of new and/or updated IT systems.
  • Bytegrid
    Vice President - Governance, Risk & Compliance
    Bytegrid Aug 2015 - Dec 2016
    Silver Spring, Maryland, Us
    Responsible for maintaining ByteGrid's Federal, State, Health & Life Science (Sidus BioData) and Financial industry compliance posture. Additionally responsible for maintaining and managing our Compliance Services group. Through our Health and Life Science division Sidus BioData, ByteGrid owns and operates the worlds largest GxP/HIPAA independent data center footprint including our fully GxP qualified, nationally deployed 'BioCloud'​ and our industry leading 'BioShare' platform..
  • Bytegrid
    Vp Quality Solutions, Health & Life Sciences
    Bytegrid Jan 2014 - Aug 2015
    Silver Spring, Maryland, Us
    Head of the Regulatory Compliance function at ByteGrid and responsible for the daily maintenance and management of the Sidus BioData Quality system as well as the management of the Compliance Services Group. Sidus offers a first in class fully qualified GxP/HIPAA Data Center Network and 21 CFR part 11 Cloud solutions as well as IT/Software Compliance services to the Life Sciences and Health Care verticals.
  • Premier Research
    Director, System Implementation & Compliance
    Premier Research Sep 2012 - Jan 2014
    Morrisville, Nc, Us
    Responsible for Global System Implementation & Compliance Group. Team acts as IT PMO, and provides validation services across our regulated clinical system inventory.
  • Qiagen
    Associate Director Verification, Validation & Software Qa
    Qiagen Jul 2010 - Sep 2012
    Venlo, Limburg, Nl
  • Qiagen
    Sr. Mgr. Computer System & Software Validation
    Qiagen Apr 2006 - Jul 2010
    Venlo, Limburg, Nl
  • Digene
    Mgr Computer Validation
    Digene 2005 - 2007
    Us
  • Alpharma / Actavis
    Computer Validation Engineer
    Alpharma / Actavis 2003 - Apr 2005
    Us
  • Cgmp Validation, Llc
    Consultant
    Cgmp Validation, Llc 2001 - 2003
    Shawnee, Kansas, Us
  • Lucent Technologies
    Project Management Specialist
    Lucent Technologies 2000 - 2002
    Espoo, Southern Finland, Fi

Stephen Ferrell Skills

Validation Quality Assurance Fda Computer System Validation 21 Cfr Part 11 Medical Devices Biotechnology Pharmaceutical Industry V&v Quality System Gxp Testing Change Control Gmp Quality Auditing Information Technology Gamp Software Quality Assurance Sop Iso 13485 Cloud Computing Quality Management Regulatory Affairs Design Control Change Management Requirements Analysis Itil Software Validation Iso 14971 Risk Management Sdlc Team Leadership Auditing Automation Hipaa Risk Assessment Sap Class Iii Medical Devices Annex 11 Healthcare It Quality Systems Process Validation Compliance Sox It Risk Crisc Healthcare Information Technology Qsr Iec62034 Cgmp

Stephen Ferrell Education Details

  • Penn State University
    Penn State University
    Management Science & Information Systems
  • Queen Margaret Academy, Ayr
    Queen Margaret Academy, Ayr

Frequently Asked Questions about Stephen Ferrell

What company does Stephen Ferrell work for?

Stephen Ferrell works for Ispe

What is Stephen Ferrell's role at the current company?

Stephen Ferrell's current role is Chair GAMP Americas.

What is Stephen Ferrell's email address?

Stephen Ferrell's email address is sf****@****ail.com

What is Stephen Ferrell's direct phone number?

Stephen Ferrell's direct phone number is +171733*****

What schools did Stephen Ferrell attend?

Stephen Ferrell attended Penn State University, Queen Margaret Academy, Ayr.

What are some of Stephen Ferrell's interests?

Stephen Ferrell has interest in Science And Technology, Ayr United Fc, Health.

What skills is Stephen Ferrell known for?

Stephen Ferrell has skills like Validation, Quality Assurance, Fda, Computer System Validation, 21 Cfr Part 11, Medical Devices, Biotechnology, Pharmaceutical Industry, V&v, Quality System, Gxp, Testing.

Who are Stephen Ferrell's colleagues?

Stephen Ferrell's colleagues are Simandan Adrian, Divya Sri Kosanam, Gogu Becali, Juan Garcia, Cop Ispe Singapore, Jacqueline Saldana, Gabriela Kantor.

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