101 to 118 of 118 GxP Jobs in the UK

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 ...

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 ...

test design, defect triage, and release confidence.Working knowledge of regulatory and compliance expectations relevant to software quality in regulated environments, including FDA, GDPR, and GxP principles.Excellent communication and presentation skills; able to craft executive-ready narratives and influence decisions.Candidate Profile – PreferredExperience in regulated environments (medical devices/healthcare) with working … knowledge of FDA expectations, GDPR, GxP, and risk-based validation approaches such as CSA.Salesforce certifications (e.g., Salesforce Administrator, Platform App Builder, or related certifications) and/or experience supporting Salesforce release management and platform upgrades.Certifications or demonstrated experience in automation engineering, Selenium/Java ecosystems, enterprise application testing, or ISTQB ...

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 ...

laboratory supplies, and biotech distribution. You will translate commercetools’ modular flexibility into trust-building messaging that addresses regulatory compliance (FDA 21 CFR Part 11, GxP,MDR), audit trail requirements, data security, and complex healthcare procurement processes. Vertical Positioning & Messaging: Develop and execute the GTM strategy for MedTech & Life Sciences, framing … including 3+ years deeply focussed on the HealthTech, MedTech & Life Sciences sectors. Clear understanding of healthcare procurement, medical device distribution, and regulatory frameworks (FDA, GxP, HIPAA, MDR). This includes 3+ years experience deeply focussed on the Industrials & Manufacturing industry sector. Strong ability to craft compelling, trust-building narratives ...

preparation and delivery of user training, management of technical documentation, enhancement of system capabilities, and collaboration with cross-functional teams. Responsibilities include supporting GxP-compliant system validation activities, user acceptance testing, and participation in regulatory inspections and internal audits as needed. The Associate Director will work directly with business stakeholders … development support. Oversee system lifecycle activities including requirements gathering, design, testing, validation, deployment, and ongoing support. Ensure delivery of high-quality solutions that meet GxP, regulatory, security, and data integrity requirements. Partner with Quality and Validation teams to support system validation, audit readiness, and inspection activities. Drive continuous improvement initiatives ...

legacy ECC through a phased, multi wave rollout across multiple regions and sites, delivered alongside leading systems integrators. This is a fully validated, GxP regulated environment where quality processes are business critical and audit readiness is non negotiable. The role As an SAP QM Process Lead you will … CAPA touchpoints Leading Batch Release Hub (BRH) design and integration for streamlined, compliant batch disposition and release Ensuring batch management, genealogy and traceability meet GxP and regulatory requirements Driving integration of QM with PP-PI, MM, MES and LIMS Running design workshops, fit gap analysis and template to regional localisation ...

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 ...

that support: SDTM and ADaM review; Dataset comparison;Metadata review;TLF review and quality control; Clinical data visualization, Statistical reporting.Develop applications in accordance with GxP, Computer Software Assurance (CSA), and company standards.Develops and executes application testing, including unit, integration, and regression testing.Provides technical consultation on R programming, R Shiny development … performance optimization at various levels (frontend, backend, infrastructure). Experience in validating RShiny applications to meet regulatory standards such as FDA, EMA, and GxP guidelines. Demonstrated experience building tools, macros, or pipelines that improved efficiency or standardization for a programming function. Active participation in the open-source community, particularly ...

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 ...

fully aligned, informed, and motivated to achieve world-class results Requirements Extensive program leadership experience (7+ years) delivering enterprise-scale R&D or GxP technology programs in Pharma (Clinical, Regulatory, or Safety) Deep understanding of Pharmaceutical R&D functions such as Clinical Operations, Regulatory Affairs, Safety, Quality, or Manufacturing Proven … Veeva Vault implementation (e.g., Clinical, RIM, Quality, Safety) Previous experience with large-scale Software as a Service (SaaS) implementations in the highly regulated GxP environment Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. As an equal opportunity ...

Amgen is seeking a Senior Manager, Instructional Designer to lead and shape training across GxP learning programs. You will drive material development, curricula, and assessment design to support regulatory compliance and product quality. You will collaborate with governance and subject-matter experts, ensuring content accuracy, accessibility, and end-user usability. ...

strategies across global programmes. Influence development programs through AI innovation, clinical development, operations, regulatory compliance, and commercialisation. Hands-on with QMS improvement and full GxP compliance. Support CTA, IND, IMPD, MAA and broader regulatory submission activities. Lead cross-functional programmes spanning Regulatory Affairs, Quality, Clinical Development and AI teams. Partner … frameworks. Strong understanding of drug development and global regulatory pathways. Experience supporting CTA, IND, IMPD, and marketing application activities. Hands-on experience with GxP, Quality Systems and regulatory compliance. Ability to work effectively across AI, scientific, regulatory and development teams. Experience within gene therapy, AAV, neuroscience or CNS programmes ...

Ekco: The Enterprise Architect is responsible for defining, governing, and evolving the site technology architecture for a pharmaceutical manufacturing facility operating in a regulated GxP environment. The role provides architectural leadership across IT, OT, automation, manufacturing execution, laboratory, quality, engineering, warehouse, serialisation, utilities, and enterprise systems to ensure technology supports … priorities, product pipeline needs, quality requirements, engineering constraints, and regulatory expectations into target-state architectures and practical transition plans. Provide architecture governance for site GxP systems, ensuring alignment with enterprise standards, site validation expectations, GMP controls, data integrity principles, cybersecurity requirements, and operational resilience needs. #J-18808-Ljbffr ...

Amgen is seeking a Sr Manager, Instructional Designer to partner with Governance and drive effective GxP Learning programs. You will design instructor-led, virtual, e-learning, blended learning, and performance-support materials, translating complex regulated content into clear training solutions. You will lead curriculum development, ensure regulatory compliance, assess outcomes ...

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 ...