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📌 Background Information -Experienced pharmaceutical and biotechnology professional with expertise in quality assurance, computer system validation (CSV), regulatory guidelines, sponsor audits, and regulatory inspections. 🎯 What We DoI specialize in implementing processes and validating computer systems to meet 21 CFR §11, FDA/EMA regulations, ICH-GCP, and Eudralex guidelines. With a deep understanding of CSV, regulatory compliance, and cloud technology, I possess the technical skills needed to M&A other company's SDLC processes, computer applications, and electronic document and data management systems.Currently specializing in Cloud and DevOps technologies through the implementation of projects based on real-world scenarios with focus on technologies and services from AWS, MS Azure, Google Cloud and Oracle Cloud with the objective of supporting companies in their digital transformation from on-premise to the Cloud. Learn more about these Cloud projects by visiting:https://medium.com/@martinmansfieldphd🛠️ How We Do ItWith a strong background in project planning, computer system validation, risk assessments, vendor audits, and vendor selection, I ensure the seamless integration of bespoke and COTS computer systems. My expertise extends to cloud, on-premise, and hybrid computer systems, AI and ML tools and applications, cGxP regulations and guidelines, GMP | GLP | GCP, application validation and infrastructure qualification.🚀 Your Next StepWhether you're in the pharmaceutical, biotechnology, or medical device industries, I can bring my expertise as a Consultant or Contractor to your organization. 📞 Call to ActionReady to ensure regulatory compliance and streamline your processes? Let's connect and explore how we can work together to achieve your goals.
Home Based
View- Website:
- hme-based.eu
- Employees:
- 1305
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Home BasedChapel Hill, Nc, Us
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Professional Development - Pharmaceutical | Biotechnology It, Csv & Cloud ComplianceHome Based Jul 2023 - PresentNamur, B-, BeRetraining for the next phase of my career: * Evyrgreen AI training to learn AI techniques for networking and posting in LinkedIn (completed 31JAN2024).* Completing Cloud Bootcamp training course to attract contract work supporting multi-cloud (AWS, Azure, GCP, OCI,DevOp) digital transformation, M&As, CSV process consolidation, and regulatory defense of cloud-based computer systems (in progress).
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Director, It ComplianceIqvia Aug 2022 - Jun 2023Durham, North Carolina, UsImplemented IQVIA's validation document access portal for large Sponsors (> $100M/year) to reduce document preparation and review times for PAI of drugs post-clinical study. Leveraged IT systems to provide near-real time access to validation documents, reduce audit frequencies and reduce audit costs by 10%.Represented IQVIA in 50+ sponsor audits of SLC/CSV deliverables to win new business and protect current revenue streams of $50M+/year.Trained global staff in CSV and technical writing for validation deliverables to meet IQVIA's goal of Right-First-Time, No-rework.Revised/authored CSV Documents for 15 Clinical Operations computing systems to meet Sponsor and regulatory requirements. -
Sr. Manager, TqmParexel International Sep 2021 - Jul 2022Implemented paperless qualification of Cloud infrastructure using automated scripts and DevOps, reducing qual. times by 25% .Validation of a bespoke Risk Categorization and Assessment Tool for Risk Based Quality Management (RBQM) to target risk areas and reduce study completion time/cost.Qualified of Alation (ML tool) which builds clean, big data catalogs for consumption in the Corporate Data Lake.Qualified Innoplexus AnalytiKa (AI/ML tools) to mine relevant documents and analytics from various public clinical data sources.Qualified ConcertAI (AI tool) that builds cohorts for trial feasibility and research execution from real world oncology data.Improved employee retention of GCP concepts by transforming static training to an engaging learning experience using AI tools (Qstream, Trivie).
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Sr. Manager, It QaThermo Fisher Scientific Jul 2016 - May 2021Waltham, Ma, UsM&A - Performed regulatory gap assessments on IT technology and GxP computer systems and delivered validation plans for the system integration of Viral Vector, mRNA-based, and plasmid DNA vaccine sites, plus protein manufacturing sites into Thermo Fisher's pharmaceutical services group to reduce overall validation execution times by 25%.Active Directory Refactoring Project - Completed re-architecture, infrastructure qualification and document development of the Thermo Forest, DCs, domains, OUs and GPOs for 650+ ThermoFisher sites. Reduced domain costs by 25%.Developed Quality Management System (QMS) for Thermo Fisher's Qualification Life Cycle (QLC) in the Pharma Group; assured compliance of IT security polices with FDA, MHRA and EMA guidelines for regulatory inspection.Performed Quality Management Reviews (QMRs) by monitoring global enterprise IT infrastructure using 25 custom Key Performance Indicators (KPIs) based on GAMP5, the US CFRs and EudraLex,Vol. 4, Annex 11.Developed/implemented Thermo Fisher's global IT vendor audit process and applied it to AWS, Azure, SAP/SF-LMS, and GitHub to close a critical FDA CAPA.Developed/implemented Thermo's global IT vendor audit process and applied it to AWS, Azure, SAP/SF-LMS, and GitHub to close a critical FDA CAPA. -
Validation Specialist/Project ManagerBasf, Agricultural Solutions Jan 2012 - Jul 2016Ludwigshafen, DeAuthored the System Development Life Cycle (SDLC) to meet EPA regulatory guidelines for the functional and design requirements and system/user acceptance testing.Assessed the appropriate risk levels for requirements so that high risk functions in computer systems are adequately tested and any risk to BASF's revenue stream are <10%.Maintained traceability of test cases to requirements and test workflows for reusability and regulatory inspection and to reduce findings to 0.Tracked/reported/retested/closed defects found during validation cycles and present statements to senior management regarding the quality of BASF computer systems.Interacted directly with EPA/FDA authorities to discuss current validation issues and place BASF in the forefront of compliance with the Code of Federal Regulations and OECD. -
Sr. It Analyst - Clinical SystemsDuke Clinical Research Institute Feb 2009 - Dec 2011Durham, North Carolina, UsImplemented Unified Functional Test (UFT) for the automation of clinical trial applications using Siebel, Web and .NET add-ins. Reduced testing time by 30% through automation and reusability of automated scripts.Automated the validation of Clinical Trial Management systems and Clinical CRM business applications developed in Siebel 8 and Java/Spring using Agile and Waterfall methodologies.Validated the DCRI's first Data Warehouse/Dashboard applications using Informatica ETL middleware to extract, transform and load from multiple application data sources; applications include multimilliondollar Hep C trials and DCRI Business reporting.
Martin Mansfield Skills
Martin Mansfield Education Details
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The Cloud BootcampMulticloud Bootcamp -
University Of Tennessee, KnoxvilleAnalytical Chemistry + Computer Engineering
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Texas A&M UniversityGeneral + Chemistry
Frequently Asked Questions about Martin Mansfield
What company does Martin Mansfield work for?
Martin Mansfield works for Home Based
What is Martin Mansfield's role at the current company?
Martin Mansfield's current role is 🔬💻 Martin Mansfield | Cloud Engineer | Computer System Validation Specialist | Pharmaceutical & Biotechnology IT 💻🔬Available for work 01DEC2024.
What is Martin Mansfield's email address?
Martin Mansfield's email address is mt****@****ail.com
What is Martin Mansfield's direct phone number?
Martin Mansfield's direct phone number is +191930*****
What schools did Martin Mansfield attend?
Martin Mansfield attended The Cloud Bootcamp, University Of Tennessee, Knoxville, Texas A&m University.
What are some of Martin Mansfield's interests?
Martin Mansfield has interest in Poverty Alleviation.
What skills is Martin Mansfield known for?
Martin Mansfield has skills like Sop, Fda, Quality Control, Validation, Sdlc, Biotechnology, 21 Cfr Part 11, Testing, Lims, Medical Devices, Sharepoint, Pharmaceutical Industry.
Who are Martin Mansfield's colleagues?
Martin Mansfield's colleagues are Ab Faila, Adrian Brown, Sandeep Maan, Margaret John, Lendee Gaco, Rawda Badr El-Dien Ahmed Ragab, Katrina Mae Carisma.
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