Quality System Manager

pStep into a bGxP Systems Quality Lead /b role where Quality expertise meets emerging technology. You will help ensure AI enabled solutions, cloud environments and computerised systems are implemented and governed in line with GxP requirements while enabling pragmatic, risk based ways of working. /p pWe offer competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance and a company car). You also get the opportunity to shape your future through personalised training and development. /p pAt MindCapture, you choose what you love, build on your strengths and make a difference where it matters most. /p pYou will work as a MindCapture consultant for an international market leader in the healthcare industry. /p h3Job Description /h3 ul liAct as a GxP Systems Quality and QA Subject Matter Expert for technology related activities /li liProvide independent Quality oversight throughout the lifecycle of GxP computerised systems, technology solutions and supporting infrastructure /li liAssess the GxP impact, intended use and regulatory requirements of new and existing technologies /li liProvide Quality oversight for AI enabled systems and use cases, covering risk classification, governance, data integrity, traceability, supplier considerations, lifecycle controls and regulatory compliance /li liSupport the development and implementation of risk based Quality frameworks for AI and other emerging technologies /li liProvide Quality oversight for IT and cloud infrastructure, including infrastructure qualification, cloud services, platform changes, supplier qualification and shared responsibility models /li liPartner with technology teams on the implementation and evolution of cloud platforms and services while ensuring appropriate GxP controls /li liReview and approve risk assessments, qualification and validation strategies, change controls, deviations and periodic reviews from a QA perspective /li liProvide QA oversight for changes, incidents, deviations and CAPAs related to computerised systems and technology infrastructure /li liContribute to policies, SOPs, standards and governance covering GxP systems, AI, infrastructure and computerised systems /li liEnsure compliance with applicable GxP requirements, 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and Data Integrity principles /li liProvide Quality input into supplier assessments for SaaS, cloud, infrastructure and AI technology providers /li liSupport regulatory inspections and internal and external audits as a GxP Systems Quality Subject Matter Expert /li liMonitor emerging regulatory expectations and translate them into practical Quality requirements /li /ul h3Requirements /h3 ul liMaster’s degree in a scientific, engineering, IT or related discipline, or equivalent experience /li liSignificant Quality Assurance experience within a GxP regulated pharmaceutical or biotech environment /li liStrong understanding of computerised systems compliance and Quality oversight throughout the system lifecycle /li liDemonstrated expertise in AI within a regulated environment, ideally covering governance, risk assessment, lifecycle management or Quality oversight of AI enabled solutions /li liStrong knowledge of IT and cloud infrastructure with an understanding of GxP compliance and qualification requirements /li liExperience with cloud technologies and service models including SaaS, PaaS and IaaS /li liStrong knowledge of GAMP 5, EU GMP Annex 11, 21 CFR Part 11, Data Integrity principles and relevant GxP requirements /li liExperience providing QA oversight for changes, deviations, CAPAs, periodic reviews and supplier qualification related to computerised systems /li liAbility to assess emerging technologies from a Quality and risk perspective using pragmatic, risk based approaches /li liExperience collaborating with IT teams, system owners, business stakeholders and technical Subject Matter Experts /li liExperience with modern technology environments, data platforms, cloud technologies or infrastructure is preferred /li liExperience supporting regulatory inspections and audits related to computerised systems or technology solutions is preferred /li liStrong stakeholder management skills with the confidence to challenge constructively and make pragmatic Quality decisions /li liComfortable working in a rapidly evolving environment where processes and governance continue to develop /li liFluent in English /li /ul pAre you ready to make a real difference in healthcare? /p pIf MindCapture sees a potential fit, we’ll get in touch as soon as possible. /p pIf you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep

your profile
in mind for future roles that could suit you better. /p