76 to 94 of 94 GxP Jobs in England

datasets. Quality & AI-Driven Compliance: Lead Test-Driven Development (TDD) and Behavior-Driven Development (BDD) initiatives. Use AI test generators to produce HIPAA/GxP-compliant synthetic clinical trial datasets for automated validation. Leverage AI tools to auto-draft validation artifacts, data lineage manifests, and audit documentation required under GxP … quality checks. Domain & Regulatory Awareness: Strong foundational understanding of clinical trial data workflows (e.g., EDC architectures), healthcare data models, and life science compliance standards (GxP, HIPAA, GDPR), with the ability to apply AI/ML tools for schema mapping and zero-loss data integrity verification . Base ...

features across asset teams; contracting vendors on outcomes and holding teams to account for quality, pace and measurable value. Embed quality, risk and compliance , GxP, privacy and AI governance, from the outset, ensuring transparent, auditable platforms and good hygiene in core systems of record. Build trusted partnerships and influence … building high-performing product teams. Experience delivering AI, data and analytics-enabled products on modern data platforms and cloud technologies. Experience operating in a GxP/validated-systems context, with strong data integrity, quality and compliance judgement. Preferred Qualifications Deep experience with structured content management, modular document design or publications ...

environment, supporting mission‐critical applications that enable research, clinical processes. The role has a direct impact on compliance with global regulatory standards (e.g., GxP/CSV), ensuring system reliability, and uninterrupted delivery of ongoing innovation initiatives. You will work on complex, integrated platforms leveraging modern engineering practices and tools (e.g. … system integrations, ensuring timely issue resolution. Drive end-to-end compliance activities including validation documentation, audit readiness, and adherence to regulatory standards (CSV/GxP). Oversee multiple concurrent workstreams with competing priorities in resource-constrained environments, ensuring optimal delivery outcomes. Proactively manage risks, issues, and schedule pressures, implementing mitigation ...

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 ...

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 ...

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 ...

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 ...

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 ...