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csv and data integrity manager
Senior Manager, GxP GDBT Service and Business Systems
ed Resourcing Ltd
Senior Manager, Service & Business Systems Location: Hertfordshire (Hybrid) Type: Permanent Full Time Shape the Future of Digital Manufacturing We're partnering with a global pharmaceutical organisation, to recruit a Senior Manager, Service & Business Systems . This is a rare opportunity to join the senior leadership team and play a pivotal role in shaping the digital future of a highly regulated manufacturing environment. You'll be responsible for the strategy, performance, resilience and compliance of the business-critical systems that support the manufacture and supply of medicines to patients around the world. This is far more than an operational IT leadership role. It's a strategic position at the intersection of technology, manufacturing, quality and business transformation. The Opportunity As the senior technology leader for the manufacturing site, you will: Develop and deliver the site's digital and business systems strategy. Lead the performance, resilience and compliance of GxP-regulated business systems. Drive digital transformation and smart manufacturing initiatives. Partner with senior stakeholders across Manufacturing, Quality, Engineering, Supply Chain and Global IT. Lead a specialist team covering Manufacturing Systems, Operational Technology (OT), Laboratory Systems, Supply Chain Systems, Computer System Validation (CSV), Serialization and IT Services. Own the digital portfolio, prioritising investments and overseeing strategic programmes. Ensure business continuity, regulatory compliance, audit readiness and data integrity across critical manufacturing systems. Build high-performing teams while developing capability and driving continuous improvement. Represent the manufacturing site within regional and global technology governance forums. About You We're looking for an experienced technology leader who thrives in a regulated manufacturing environment and enjoys combining strategic leadership with operational excellence. You'll bring: Significant leadership experience within pharmaceutical manufacturing or another highly regulated industry. Strong knowledge of GxP environments and validated systems. Experience with Computer System Validation (CSV), change control, data integrity and regulatory compliance. A proven track record of leading manufacturing or business systems supporting operational environments. Experience developing digital strategy, governance and transformation initiatives. Strong people leadership with experience building and developing high-performing teams. Excellent executive stakeholder management and influencing skills. Commercial experience managing suppliers, budgets and strategic vendor relationships. Desirable Experience Pharmaceutical, biotechnology or medical device manufacturing. Manufacturing Systems, MES, LIMS, ERP or Operational Technology (OT). IT Service Management and Business Continuity Planning. ITIL, PRINCE2, PMP, Agile or similar professional certifications. Why Join? This is an opportunity to influence technology strategy at both site and regional level while supporting the manufacture of medicines that improve patients' lives. You'll benefit from: A senior leadership position with significant visibility across the business. The opportunity to shape digital transformation within a global pharmaceutical organisation. Ownership of critical GxP-regulated systems supporting manufacturing operations. Exposure to regional and global technology initiatives. Leadership of a highly skilled multidisciplinary team. A collaborative culture focused on innovation, continuous improvement and patient outcomes. Hybrid working.
Jul 28, 2026
Full time
Senior Manager, Service & Business Systems Location: Hertfordshire (Hybrid) Type: Permanent Full Time Shape the Future of Digital Manufacturing We're partnering with a global pharmaceutical organisation, to recruit a Senior Manager, Service & Business Systems . This is a rare opportunity to join the senior leadership team and play a pivotal role in shaping the digital future of a highly regulated manufacturing environment. You'll be responsible for the strategy, performance, resilience and compliance of the business-critical systems that support the manufacture and supply of medicines to patients around the world. This is far more than an operational IT leadership role. It's a strategic position at the intersection of technology, manufacturing, quality and business transformation. The Opportunity As the senior technology leader for the manufacturing site, you will: Develop and deliver the site's digital and business systems strategy. Lead the performance, resilience and compliance of GxP-regulated business systems. Drive digital transformation and smart manufacturing initiatives. Partner with senior stakeholders across Manufacturing, Quality, Engineering, Supply Chain and Global IT. Lead a specialist team covering Manufacturing Systems, Operational Technology (OT), Laboratory Systems, Supply Chain Systems, Computer System Validation (CSV), Serialization and IT Services. Own the digital portfolio, prioritising investments and overseeing strategic programmes. Ensure business continuity, regulatory compliance, audit readiness and data integrity across critical manufacturing systems. Build high-performing teams while developing capability and driving continuous improvement. Represent the manufacturing site within regional and global technology governance forums. About You We're looking for an experienced technology leader who thrives in a regulated manufacturing environment and enjoys combining strategic leadership with operational excellence. You'll bring: Significant leadership experience within pharmaceutical manufacturing or another highly regulated industry. Strong knowledge of GxP environments and validated systems. Experience with Computer System Validation (CSV), change control, data integrity and regulatory compliance. A proven track record of leading manufacturing or business systems supporting operational environments. Experience developing digital strategy, governance and transformation initiatives. Strong people leadership with experience building and developing high-performing teams. Excellent executive stakeholder management and influencing skills. Commercial experience managing suppliers, budgets and strategic vendor relationships. Desirable Experience Pharmaceutical, biotechnology or medical device manufacturing. Manufacturing Systems, MES, LIMS, ERP or Operational Technology (OT). IT Service Management and Business Continuity Planning. ITIL, PRINCE2, PMP, Agile or similar professional certifications. Why Join? This is an opportunity to influence technology strategy at both site and regional level while supporting the manufacture of medicines that improve patients' lives. You'll benefit from: A senior leadership position with significant visibility across the business. The opportunity to shape digital transformation within a global pharmaceutical organisation. Ownership of critical GxP-regulated systems supporting manufacturing operations. Exposure to regional and global technology initiatives. Leadership of a highly skilled multidisciplinary team. A collaborative culture focused on innovation, continuous improvement and patient outcomes. Hybrid working.
Adecco
Quality Validation Officer (CSV)
Adecco
Quality Validation Officer (CSV) Are you passionate about ensuring quality and compliance in the healthcare sector? Do you thrive in dynamic environments where your expertise can make a real impact? If so, we have an exciting opportunity for you to join our client as a Quality Validation Officer! Location: Hybrid - West and East Midlands Your Role: As a proactive Quality Validation Officer, you'll play a crucial role in supporting computerised system validation and quality assurance activities. Working closely with the Validation Manager, you will ensure that systems-including SAP-meet the highest standards of GDP, ISO, FDA, and EU annexe 11 compliance. Your Tasks Will Include: Leading and supporting Computer System Validation (CSV) activities, including planning, executing, and documenting validation and change controls. Preparing and reviewing test documentation, validation protocols, and change requests to guarantee that all system changes are justified, tested, approved, and compliant. Conducting effectiveness checks and data integrity reviews to maintain ongoing compliance. Assisting with deviations, CAPAs, risk assessments, change controls, and SOP creation within the Quality Management System (QMS). Providing QA support and guidance to operational teams, ensuring project timelines and compliance requirements are met. Delivering training sessions on validation and key quality processes to boost compliance awareness across teams. Participating in internal and external audits, supporting audit readiness, and contributing to CAPA closure. Supporting quality metrics and KPI reporting, ensuring timely completion of QMS actions. Contributing to supplier validation, including performance reviews and maintenance of validation schedules for critical equipment. Your Profile: To excel in this role, you should have: Experience with SAP or other enterprise systems, electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence in audits, inspections, and presenting validation activities. Client Offers: 25 days of annual leave plus 8 UK bank holidays, with the option to purchase up to an additional 5 days. A competitive pension contribution. A life assurance policy that pays out 4 times your salary. An Employee Assistance Programme for confidential support and advice. An Employee Discount Scheme through Treats. Free car parking. Apply Now! Don't miss your chance to make a difference. Take the next step in your career and join our enthusiastic team! Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.
Jan 20, 2026
Full time
Quality Validation Officer (CSV) Are you passionate about ensuring quality and compliance in the healthcare sector? Do you thrive in dynamic environments where your expertise can make a real impact? If so, we have an exciting opportunity for you to join our client as a Quality Validation Officer! Location: Hybrid - West and East Midlands Your Role: As a proactive Quality Validation Officer, you'll play a crucial role in supporting computerised system validation and quality assurance activities. Working closely with the Validation Manager, you will ensure that systems-including SAP-meet the highest standards of GDP, ISO, FDA, and EU annexe 11 compliance. Your Tasks Will Include: Leading and supporting Computer System Validation (CSV) activities, including planning, executing, and documenting validation and change controls. Preparing and reviewing test documentation, validation protocols, and change requests to guarantee that all system changes are justified, tested, approved, and compliant. Conducting effectiveness checks and data integrity reviews to maintain ongoing compliance. Assisting with deviations, CAPAs, risk assessments, change controls, and SOP creation within the Quality Management System (QMS). Providing QA support and guidance to operational teams, ensuring project timelines and compliance requirements are met. Delivering training sessions on validation and key quality processes to boost compliance awareness across teams. Participating in internal and external audits, supporting audit readiness, and contributing to CAPA closure. Supporting quality metrics and KPI reporting, ensuring timely completion of QMS actions. Contributing to supplier validation, including performance reviews and maintenance of validation schedules for critical equipment. Your Profile: To excel in this role, you should have: Experience with SAP or other enterprise systems, electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence in audits, inspections, and presenting validation activities. Client Offers: 25 days of annual leave plus 8 UK bank holidays, with the option to purchase up to an additional 5 days. A competitive pension contribution. A life assurance policy that pays out 4 times your salary. An Employee Assistance Programme for confidential support and advice. An Employee Discount Scheme through Treats. Free car parking. Apply Now! Don't miss your chance to make a difference. Take the next step in your career and join our enthusiastic team! Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.

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