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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).
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Chair Gamp AmericasIspePhiladelphia, Pa, Us -
Chief Strategy OfficerStrike Graph May 2024 - PresentSeattle, Wa, UsHelping customers accelerate their compliance journey and maintain a pragmatic, risk aware security posture. -
Co-Chair Ispe Gamp AmericasIspe Oct 2023 - PresentNorth Bethesda, Maryland, UsServing as co-Chair of GAMP Americas alongside the brilliant Brandi Stockton and Levi Schenk. -
Beachhead Advisor - Life Sciences (Nz Gov)New Zealand Trade And Enterprise Jan 2022 - PresentAuckland, NzAs 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. -
Vp It Governance & Software AssuranceCompliancepath Limited - An Ideagen Company Jan 2014 - May 2024Glasgow, GbCo-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. -
Adjunct Lecturer, Temple University, School Of Pharmacy, Ra/Qa Graduate ProgramTemple University School Of Pharmacy Nov 2020 - Jan 2022Philadelphia, Pennsylvania, UsLecturing on IT Governance and Software Assurance in the Life Sciences. -
Managing Partner -ProductPromedim Oct 2014 - Nov 2021London, England, GbPromedim 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. -
Vp Operations & CcoRuro, Inc. Apr 2018 - Mar 2020Supporting 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.
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Vice President, Product StrategyBytegrid Oct 2017 - Apr 2018Silver Spring, Maryland, UsSupporting 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. -
Sr. Director, It ComplianceThermo Fisher Scientific Dec 2016 - Nov 2017Waltham, Ma, UsResponsible 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. -
Vice President - Governance, Risk & ComplianceBytegrid Aug 2015 - Dec 2016Silver Spring, Maryland, UsResponsible 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.. -
Vp Quality Solutions, Health & Life SciencesBytegrid Jan 2014 - Aug 2015Silver Spring, Maryland, UsHead 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. -
Director, System Implementation & CompliancePremier Research Sep 2012 - Jan 2014Morrisville, Nc, UsResponsible for Global System Implementation & Compliance Group. Team acts as IT PMO, and provides validation services across our regulated clinical system inventory. -
Associate Director Verification, Validation & Software QaQiagen Jul 2010 - Sep 2012Venlo, Limburg, Nl -
Sr. Mgr. Computer System & Software ValidationQiagen Apr 2006 - Jul 2010Venlo, Limburg, Nl -
Mgr Computer ValidationDigene 2005 - 2007Us -
Computer Validation EngineerAlpharma / Actavis 2003 - Apr 2005Us -
ConsultantCgmp Validation, Llc 2001 - 2003Shawnee, Kansas, Us -
Project Management SpecialistLucent Technologies 2000 - 2002Espoo, Southern Finland, Fi
Stephen Ferrell Skills
Stephen Ferrell Education Details
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Penn State UniversityManagement Science & Information Systems -
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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