51 to 75 of 77 GxP Jobs in the UK

applicable regulations, and internal quality standards. Lead the implementation, improvement and validation of new processes, procedures, and IT systems (e.g., eQMS, eTMF) to support GxP compliance and operational excellence. Oversee internal and external audits, including regulatory inspections, ensuring findings are addressed promptly and effectively Cross-Functional Collaboration & Leadership Partner with … Clinical Operations, IT, Engineering, and Science Teams to integrate quality and regulatory requirements into digital platforms, AI-enabled solutions, and GxP-relevant systems. Embed a culture of quality awareness through training, workshops, and mentoring, ensuring all staff are competent and compliant with GCP, ISO standards, and internal policies. Support ...

applicable regulations, and internal quality standards. Lead the implementation, improvement and validation of new processes, procedures, and IT systems (e.g., eQMS, eTMF) to support GxP compliance and operational excellence. Oversee internal and external audits, including regulatory inspections, ensuring findings are addressed promptly and effectively Cross-Functional Collaboration & Leadership Partner with … Clinical Operations, IT, Engineering, and Science Teams to integrate quality and regulatory requirements into digital platforms, AI-enabled solutions, and GxP-relevant systems. Embed a culture of quality awareness through training, workshops, and mentoring, ensuring all staff are competent and compliant with GCP, ISO standards, and internal policies. Support ...

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 ...

multiplier, aligning stakeholders across science, engineering, clinical, and commercial teams. Bring discipline to delivery in a complex environment spanning AI/ML development and GxP-regulated processes Influence at all levels, using judgment, credibility, and soft power to navigate competing priorities Establish best-in-class programme management practices, tools … medtech, or pharma. Experience supporting: Customer deployments Enterprise/pharma partnerships Ability to connect technical delivery with business outcomes. Familiarity with regulated environments e.g. GxP clinical trials, healthcare/medical devices, life sciences. Demonstrated ability to lead through influence, not just authority – high emotional intelligence and political nuance are essential. ...

Summary of the role: As a Validation Lead you will partner directly with pharma clients in London, ensuring CSV and GxP compliance for emerging AI and GenAI systems. This role is client‐facing, focused on closing validation requirements, resolving compliance gaps, and providing assurance that regulatory expectations are fully met. … Experience & Background - 15+ years in IT within pharma/life sciences environments - Deep expertise in CSV and GxP compliance, with a strong regulatory focus - Proven track record of delivering validation programs for AI and GenAI systems in regulated settings Core Expertise - End-to-end validation strategy and execution for GxP ...

templates, assessments, remediation plans and change controls for key or critical systems. - Review and approve key validation and project lifecycle documentation, including validation plans, GxP assessments, data migration plans, functional risk assessments, UAT/PQ test reports, validation reports, data migration reports and go/no-go decisions where appropriate. … quality, compliance, IT, systems or business-related discipline, or equivalent practical experience overseeing computerised systems in a regulated or compliance-led environment. - Experience in GxP, ERES, pharmaceutical, chemical, manufacturing, life sciences or another highly regulated environment. - Experience of Computer Systems Validation, system lifecycle documentation, change control and periodic review ...

templates, assessments, remediation plans and change controls for key or critical systems. - Review and approve key validation and project lifecycle documentation, including validation plans, GxP assessments, data migration plans, functional risk assessments, UAT/PQ test reports, validation reports, data migration reports and go/no-go decisions where appropriate. … quality, compliance, IT, systems or business-related discipline, or equivalent practical experience overseeing computerised systems in a regulated or compliance-led environment. - Experience in GxP, ERES, pharmaceutical, chemical, manufacturing, life sciences or another highly regulated environment. - Experience of Computer Systems Validation, system lifecycle documentation, change control and periodic review ...

developing and implementing validation strategies for aseptic processing, sterilisation, and equipment qualification across all manufacturing sites. The role is also responsible for overseeing GxP Computerised System Validation activities, ensuring a high-performing Validation team that supports manufacturing operations while maintaining regulatory compliance. Main Activities/Tasks Provide strategic and technical … sites. Develop, implement and continuously improve the company's validation master strategy for: Equipment qualification Facilities and utilities qualification Sterilisation validation Aseptic processing validation GxP Computer Systems Validation (CSV) Ensure validation programmes comply with current GMP, international regulatory requirements and recognised industry standards. Lead the development, review and approval ...

cloud-based and regulated environments Driving audit readiness, compliance programs and evidence-based assurance across frameworks such as ISO 27001, GDPR, SOC 2 and GxP Providing leadership on risk management, governance and security strategy Partnering with customers, auditors and key stakeholders on security reviews, assurance activities and regulatory compliance Supporting … several of the following areas: Security leadership, governance, risk and compliance (GRC) Cloud security architecture and security strategy ISO 27001, GDPR, SOC 2, GxP, 21 CFR Part 11 or similar regulated frameworks Audit leadership, customer assurance and certification programs Healthcare technology, pharmaceutical, biotechnology or regulated SaaS environments Customer-facing security ...

effective IT service desk and provide hands‐on technical support. Develop cybersecurity, data protection and information security frameworks. Support UK GDPR, ISO 27001, GxP and other relevant regulatory requirements. Lead business continuity, disaster recovery, patching and vulnerability management. Select and implement systems such as ERP, CRM, HR and collaboration platforms. … explain technical subjects clearly to non‐technical stakeholders. A practical, commercially aware and solutions‐focused approach. Experience with LIMS, ELN platforms, laboratory systems, GxP, MHRA guidance or FDA 21 CFR Part 11 would be particularly valuable. What’s next? If you are an experienced IT leader who enjoys combining strategy ...

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 ...

Moderna is expanding its Harwell operations to support advanced GxP manufacturing automation systems. You will help ensure automated platforms operate reliably, compliantly, and efficiently while contributing to the future of biotechnology. As a Senior Engineer, Process Automation, you will work with Aveva, Rockwell, DeltaV, Syncade, Apprentice Tempo, and Aveva ...

Recruitment Ltd is seeking a Senior Manager to lead GxP GDBT Service and Business Systems at a major pharmaceutical site in Hertfordshire. You will own the digital strategy for manufacturing systems, ensure CSV compliance, data integrity and regulatory readiness across critical platforms. You will steer a multidisciplinary team, partner with ...

performance, including obsolescence management and application of functional and safety standards Develop and maintain procedures for integration of IT and IACS systems in both GxP and non-GxP environments Support development of OT architecture, standards, and governance, and collaborate with global and local stakeholders Drive communication and change management within … Experience with industrial automation systems and OT architecture, including integration with IT systems Familiarity with regulated environments and standards such as GxP (including GMP and GAMP5) and IEC 61508/61511 Understanding of cyber security risk assessments, controls, and system documentation Experience in system lifecycle management, including validation, change control ...

performance, including obsolescence management and application of functional and safety standards Develop and maintain procedures for integration of IT and IACS systems in both GxP and non-GxP environments Support development of OT architecture, standards, and governance, and collaborate with global and local stakeholders Drive communication and change management within … Experience with industrial automation systems and OT architecture, including integration with IT systems Familiarity with regulated environments and standards such as GxP (including GMP and GAMP5) and IEC 61508/61511 Understanding of cyber security risk assessments, controls, and system documentation Experience in system lifecycle management, including validation, change control ...

applicable regulations, and internal quality standards. Lead the implementation, improvement and validation of new processes, procedures, and IT systems (e.g., eQMS, eTMF) to support GxP compliance and operational excellence. Oversee internal and external audits, including regulatory inspections, ensuring findings are addressed promptly and effectively. Partner with Clinical Operations, IT, Engineering … Science Teams to integrate quality and regulatory requirements into digital platforms, AI-enabled solutions, and GxP-relevant systems. Embed a culture of quality awareness through training, workshops, and mentoring, ensuring all staff are competent and compliant with GCP, ISO standards, and internal policies. Support the Quality Manager in maintaining ...

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 ...

System Administrator (GxP Systems) 3-Month Contract | Part-Time | Pirbright, Surrey | Inside IR35 We're looking for a System Administrator with experience supporting validated systems in regulated environments (GxP/GMP) . Key Responsibilities: System administration, maintenance, and patch management Testing and validation activities (CSV/GxP) System implementation … control and compliance activities Audit readiness and documentation Root cause analysis and issue resolution Collaborate with Engineering, Manufacturing, Quality, and external vendors Required Experience: GxP System Validation/Computer System Validation (CSV) Change Control & Patch Management Compliance & Audit Readiness System Lifecycle Management CAPA & Risk Management Vendor & Stakeholder Management Project Delivery ...

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 ...

leadership responsibility within IT in biotech, pharmaceutical, or other regulated environments Demonstrable experience in leading IT services, operating models, governance, policies, and procedures in GxP or similarly controlled settings Experience partnering with senior stakeholders across Quality, Regulatory, TechOps, Supply Chain, PV, Finance, HR, and other business functions Strong experience … plans Strong understanding of enterprise architecture principles, systems integration, and application lifecycle management in complex business environments Experience supporting compliance activities including CSV, SOX, GxP, ITGC, privacy, and audit‐related requirements Demonstrated ability to lead through influence across matrixed organisations and third‐party service models Kyowa Kirin International ...

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 ...

Competitive + great benefits An experienced senior IT leader is required for our pharmaceutical manufacturing client to take ownership of Manufacturing IT Services and GxP-regulated Business Systems across its EMEA manufacturing hub. This is a senior leadership role responsible for digital strategy, operational resilience, compliance, business continuity and technology … transformation within a regulated pharmaceutical environment. Key responsibilities: Leading Manufacturing IT Services and Business Systems. Driving digital transformation and site technology strategy. Ensuring GxP compliance, validation, data integrity and audit readiness. Managing technology portfolios, vendors and key stakeholders. Building and developing high-performing teams. Experience required: Proven IT leadership experience ...

data. Apply DAMA, FAIR and ALCOA+ principles to improve data quality, integrity, accessibility, traceability and reuse. Ensure Data Governance practices support regulated environments, including GxP, GDPR and FDA requirements. Define and maintain Data Owner, Data Steward and Governance roles with clear responsibilities and accountability. Lead Data Governance programmes and coordinate … governance models, RACI matrices, decision rights and stewardship models. Experience developing data policies, standards, procedures and governance frameworks. Experience working in regulated environments, including GxP, GDPR and FDA compliance. Strong understanding of Data Quality, Metadata, Data Lineage and Data Catalogues. Experience leading data transformation programmes and multiple workstreams. Strong stakeholder ...

project management lifecycle with customer and external vendor partners globally Leadership of projects through whole lifecycle ensuring compliance with Generis and GxP best practise methodologies, being flexible to phased deployment approaches Work collaboratively with team members to plan and implement project and major workstreams (e.g. planning sessions, daily stand … with development teams Experience overseeing the design, development and implementation of software and hardware solutions, systems or products Experience of computer system validation/GxP validated environments for regulated life sciences projects Strong track record of contributing to projects and achieving results A “customer facing”, service-oriented approach to enable ...

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 ...