Darren Stevens Email and Phone Number
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Achieving Compliance, Security, Availability, and Integrity through QualityThrough the implementation of a comprehensive and unified set of IT, SOX, GxP, InfoSec, Data Integrity, and Quality controls, a Company can achieve operational excellence and full compliance with a positive impact on business operations. To achieve these goals, I utilize my experience in the following areas:• Architecting and implementing Quality programs in highly regulated environments (e.g. GxP, SOX)• Promoting Quality, Security, and Compliance Initiatives by successfully influencing key stakeholders• Mediating optimal solutions across IT, QA, Security, and the business
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Associate Director, Gxp Systems Quality AssuranceEisai Us Jan 2022 - PresentNutley, Nj, Us
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Senior Manager, It Quality AssuranceEisai Us Dec 2020 - Dec 2021Nutley, Nj, Us
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Senior Manager, Information Protection StrategyBd Feb 2018 - Oct 2020Franklin Lakes, New Jersey, UsMember of the Global Information Security Department at BD -
Manager, It Qa @ Regeneron PharmaceuticalsRegeneron Pharmaceuticals, Inc. Jan 2015 - Feb 2018Tarrytown, New York, UsResponsible for ensuring IT is operating in compliance with regulatory requirements such as FDA GxPs and SOX as well as reporting on metrics related to the quality of delivery of services across IT. -
Associate Manager - It Quality AssuranceRegeneron Pharmaceuticals, Inc. Mar 2013 - Dec 2014Tarrytown, New York, UsResponsible for ensuring IT is operating in compliance with regulatory requirements such as FDA GxPs and SOX as well as reporting on metrics related to the quality of delivery of services across IT.
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Compliance AnalystXerox Business Services, Llc Mar 2007 - Mar 2013Xerox Business Services, LLC (formerly ACS) is a provider information technology outsourcing (ITO) solutions to clients worldwide.Responsibilities include all regulatory compliance for multiple multinational pharmaceutical clients of ITO division.Primary compliance person responsible for all qualification documentation for a complete network infrastructure build in an Xerox-owned Data Center for a large pharmaceutical client with manufacturing facilities in several countriesPrimary person responsible for all qualification document for the infrastructure for a global SAP rolloutResponsible for all document management, final review, and revision control tasks for all controlled documentationPrimary responsibility for review, revision and rewrite of all client-specific SOPs/WKIs for a pharmaceutical clientPrimary compliance team responsibility for development, review, revision and approval process for most Design Specifications and Technical Installation Plans for the infrastructure for a large pharmaceutical client.Streamlined and improved the Change Control process for a large pharmaceutical clientsStreamlined and improved the Network Infrastructure Qualification Process for a large pharmaceutical clientAssisted with the transition of the infrastructure of multiple multinational pharmaceutical clients into Xerox-owned and/or Xerox-managed data centers.Assisted with the qualification and validation of a large application suite for use by Xerox and Xerox clients Primary interface to external auditing firm for 4 consecutive annual SSAE16/SAS 70 audits in which there were no substantive findings.Primary interface to client for supporting client’s SOX compliance program, including assisting the client in supporting both internal and external SOX audits.Primary interface to internal technical groups for supporting client’s SOX compliance program, including assisting the client in supporting both internal and external SOX audits.
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Software Quality EngineerMatrix Resources (Contract Position @ Labcorp Clinical Trials Is Dept.) Aug 2006 - Mar 2007Actively participating in Software Validation Projects (primarily GCP) as a Software Quality Engineer with responsibilities that include writing, executing, and reviewing all types of validation documentation (Validation Plans, IQ, OQ, PQ, Test Cases, User Acceptance Testing (UAT), Traceability Matrices, etc.)Actively using defect management software and assisting in testing software builds for production patches/releasesSupporting Management with Regulatory Issues including the review/update of SOPs, assisting in vendor audits, consulting on project strategies, and related tasksResponsible for various document management and revision control tasks for controlled documentation
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Qa Specialist 3 (Validation)Rti International Oct 2003 - Aug 2006Research Triangle Park, Nc, UsResponsible for document review and consulting on compliance issues (as QA) for various validation projects related to computerized laboratory equipment and application software Participated in all aspects of the validation of Client-Server based custom and semi-custom LIMS-type systems including the Qualification of both the hardware (including desktop PCs, servers, interfaced equipment, etc.) and software applications (complex Oracle server-based data collection software, VMS-based systems, etc.)Responsible for actively participating in Validation Projects as a representative of the Systems and Software Validation (SSV) group, including writing, executing and reviewing all types of validation documentation (VMP, IQ, OQ, PQ, Test Cases, etc.)Responsible for 21 CFR Part 11 Compliance and Quality Assurance for the Science and Engineering Group (SEG)Responsible for verification audits and reviews for compliance to GLP, GMP, various similar guidelines, and best-practices (primarily in areas related to Validation).Developed RTI SEG Computer System Validation Infrastructure, including SOPs, Templates, Guidelines, Policies, and other Supporting Documentation primarily for all facets of pre-clinical research and Chemistry labs -
East Coast Sales And MarketingPurity Systems 2001 - 2002Quality Assurance, inspection, and testing of High Purity stainless steel piping
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Qa/QcFst Consulting 1998 - 2001Semiconductor Facility Quality Assurance with particular focus on high purity gas delivery systems and associated facility piping requirements.
Darren Stevens Skills
Darren Stevens Education Details
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Oregon State UniversityPhysics -
Suny GeneseoBs Physics & Ba Computer Science (+Minor In Mathematics)
Frequently Asked Questions about Darren Stevens
What company does Darren Stevens work for?
Darren Stevens works for Eisai Us
What is Darren Stevens's role at the current company?
Darren Stevens's current role is Expert in the Quality and Compliance of Digital Systems.
What is Darren Stevens's email address?
Darren Stevens's email address is darren_stevens@bd.com
What is Darren Stevens's direct phone number?
Darren Stevens's direct phone number is +177575*****
What schools did Darren Stevens attend?
Darren Stevens attended Oregon State University, Suny Geneseo.
What skills is Darren Stevens known for?
Darren Stevens has skills like Validation, Quality Assurance, Product Development, Itil, 21 Cfr Part 11, Change Control, Fda, Computer System Validation, Gxp, Cross Functional Team Leadership, Glp, Gmp.
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