21 of 21 GxP Jobs in the South East

business.Manage and develop the IT Support team, prioritising workloads and ensuring timely resolution of incidents, requests and user issues.Ensure IT operations remain compliant with GxP, Data Integrity, Information Security, validation and change control requirements.Own and continuously improve ITSM processes, including Incident, Request, Problem, Knowledge and Major Incident Management.Oversee IT hardware ...

develop the IT Support team, prioritising workloads and ensuring timely resolution of incidents, requests and user issues. Ensure IT operations remain compliant with GxP, Data Integrity, Information Security, validation and change control requirements. Own and continuously improve ITSM processes, including Incident, Request, Problem, Knowledge and Major Incident Management. Oversee ...

with infrastructure considerations (networking, hosting, security, etc.) in enabling on-premise and cloud IT solutions. Knowledge of data integrity and compliance standards within a GxP-regulated environment (e.g., 21 CFR Part 11). Solution architecture certifications for Microsoft Azure or Google Cloud Platform. Experience working in a product operating model ...

leadership, and the front door through which site requirements are captured, shaped, and routed into the correct cross-functional platform backlog.Operating within highly regulated GxP and SOX environments, this role remains accountable for operational excellence, financial stewardship, and risk management across a complex laboratory technology landscape, including ownership ...

reporting. Strong knowledge of GCLP/GLP guidelines preferred and requirements for phase‐appropriate validation for clinical trial biomarker/endpoints; familiarity with GxP/MHRA/GCLP/ICH expectations and inspection readiness. Proficiency with library prep (amplicon, hybrid capture, poly(A)/RNA workflows), nucleic acid extraction from ...

comparable regulatory systems experience will be considered. Strong requirements gathering, process mapping and stakeholder management skills. Agile experience, including user stories and backlog management. GxP/FDA or Computer System Validation experience would be advantageous. This is an excellent opportunity for a strong Regulatory Business Analyst to join a global ...

accountability for operational performance in complex, multi-site environments.Proven leadership of workplace services across manufacturing, laboratory, warehouse, and office environments, including experience operating within GxP and other regulated frameworks.Demonstrated success owning service performance, major incident management, and supplier delivery with a strong focus on reliability, compliance, and user experience.Excellent stakeholder ...

accountability for operational performance in complex, multi-site environments.Proven leadership of workplace services across manufacturing, laboratory, warehouse, and office environments, including experience operating within GxP and other regulated frameworks.Demonstrated success owning service performance, major incident management, and supplier delivery with a strong focus on reliability, compliance, and user experience.Excellent stakeholder ...

validated, audit-ready environments, drive platform upgrades and cloud evolution, and partner with senior leadership to deliver robust regulatory solutions. This role requires deep GxP experience and travel up to 15%. #J-18808-Ljbffr ...

intersection of Digital Technology, science, engineering, and business operations, ensuring that systems meet the highest standards of cybersecurity, data integrity, operational resilience, and GxP compliance.Who you'll work withYou will work closely with CMC Development Sciences scientists, Functional System Owners, business stakeholders, vendors, and Digital Technology colleagues to deliver reliable … define implementation roadmapsLead solution design and coordinate implementation, integration, qualification, validation, testing, and transition into operation for new and existing systemsEnsure systems comply with GxP, cybersecurity, quality, regulatory, and service management requirements while maintaining data integrity, resilience, and business continuityCollaborate with vendors, DT teams, and service component owners to resolve ...

strategy and collaborates with senior leaders to ensure compliant, scalable technology across GRAS. The role requires deep experience in regulatory operations, Veeva Vault, and GxP environments, with a track record of delivering robust, audit-ready solutions. #J-18808-Ljbffr ...

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and ...

teams. Together, you will ensure that technology solutions enhance productivity, maintain compliance, and support research innovation.What You’ll DoDefine and implement digital solutions for GxP lab automation and data managementOversee compliance of GxP IT systems, ensuring proper documentation and validationAct as the DT System Owner (DTSO … Engineering, Life Sciences, or a related fieldStrong technical affinity with IT systems and scientific instrumentation3+ years of experience in a similar role within GxP environmentsExperience in managing digital lab automation and research workflowsExperience with Modeling and Simulations tools, e.g. Nonmem, R, Python,...Knowledge of IT compliance frameworks (e.g., Computerized Systems ...

performance, including obsolescence management and application of functional and safety standardsDevelop and maintain procedures for integration of IT and IACS systems in both GxP and non-GxP environmentsSupport development of OT architecture, standards, and governance, and collaborate with global and local stakeholdersDrive communication and change management within engineering teams … 2700x and IEC 62443Experience with industrial automation systems and OT architecture, including integration with IT systemsFamiliarity with regulated environments and standards such as GxP (including GMP and GAMP5) and IEC 61508/61511Understanding of cyber security risk assessments, controls, and system documentationExperience in system lifecycle management, including validation, change control ...

Join us as a Senior IT Quality & CSV Specialist. As Senior IT Quality & CSV Specialist you will provide independent quality and validation oversight for GxP computerised systems and complex global IT projects within a pharmaceutical environment. You will work with project teams, system owners, IT teams and regulated business functions … ensure computer system validation activities are risk-based, compliant with global regulatory requirements, and inspection-ready. What you'll do: Provide quality oversight of GxP computerised systems throughout the full validation lifecycle. Review validation documentation including Validation Plans, Validation Reports, requirements, traceability matrices, design documentation, test plans, test reports, testing ...

point for the Regulatory organisation, resolving issues quickly and minimising disruption. Ensure platforms meet regulatory, data integrity, security, and inspection-readiness requirements in validated GxP environments. Oversee vendor-provided technologies and outsourced application management support. Drive lifecycle management of platforms — upgrades, enhancements, cloud evolution, and reduction of technical debt. Establish … experience with Veeva Vault Regulatory systems Working knowledge of regulatory operations, submissions and publishing, and the technology that supports them Strong experience operating within GxP settings, including system validation, inspection readiness, and data integrity Proven ability to partner with senior leadership to deliver technology solutions PV/safety experience would ...

Data Flow Documents Data Integrity Risk Assessments UAT Scripts & Execution Documentation Release Notes Business Communications Participate in system validation, periodic reviews, CAPAs, deviations and GxP compliance activities Collaborate with global stakeholders to continuously improve safety processes and supporting technologies What We're Looking For ✅ 5+ years' experience supporting Pharmacovigilance/… Drug Safety systems ✅ Strong knowledge of pharmacovigilance processes and operations ✅ Experience working within GxP-regulated environments ✅ Experience supporting validated computer systems ✅ Excellent business analysis skills with the ability to translate operational requirements into system solutions ✅ Strong stakeholder management and communication skills ✅ Experience supporting system implementations, upgrades, releases and change management ...

point for the Regulatory organisation, resolving issues quickly and minimising disruption Ensure platforms meet regulatory, data integrity, security, and inspection-readiness requirements in validated GxP environments Oversee vendor-provided technologies and outsourced application management support Drive lifecycle management of platforms upgrades, enhancements, cloud evolution, and reduction of technical debt Establish … experience with Veeva Vault Regulatory systems Working knowledge of regulatory operations, submissions and publishing, and the technology that supports them Strong experience operating within GxP settings, including system validation, inspection readiness, and data integrity Proven ability to partner with senior leadership to deliver technology solutions PV/safety experience would ...

escalation point for the Regulatory organisation, resolving issues quickly and minimising disruptionEnsure platforms meet regulatory, data integrity, security, and inspection-readiness requirements in validated GxP environmentsOversee vendor-provided technologies and outsourced application management supportDrive lifecycle management of platforms — upgrades, enhancements, cloud evolution, and reduction of technical debtEstablish platform governance, documentation … sciences industryDirect experience with Veeva Vault Regulatory systemsWorking knowledge of regulatory operations, submissions and publishing, and the technology that supports themStrong experience operating within GxP settings, including system validation, inspection readiness, and data integrityProven ability to partner with senior leadership to deliver technology solutionsPV/safety experience would also ...

business value, identify and manage cross-functional dependencies across systems, platforms, and business processes- Ensure compliance with IT&D quality standards and regulatory requirements (GxP) throughout delivery - Partner with business and IT leadership to align delivery with strategic roadmaps and priorities, as well as manage relationships with executive sponsors … Extensive experience leading large-scale, complex digital transformation programmes, ideally within PLM or related domains- Strong track record of operating in regulated environments (e.g. GxP) and ensuring compliant delivery- Proven ability to manage programme governance, financials, risks, and dependencies across global, matrixed organisations- Excellent stakeholder management skills, with experience engaging ...

LIMS implementation within a highly regulated life sciences environment. This role requires someone who has successfully delivered LIMS projects and can operate effectively in GxP and GMP-regulated environments , where data integrity, compliance, and patient safety are central to the programme's success. Key Requirements Proven experience delivering LIMS implementation … projects Experience with LabVantage LIMS Strong understanding of GxP and GMP regulations Experience managing complex stakeholder groups across business and technical teams Track record of delivering projects in highly regulated environments Contract Details 6-month initial contract Outside IR35 Potential for a multi-year engagement , with further European ...