Data integrity remediation plan lead

h3What is the mission about? /h3 pSEE JD /p h3Job Description /h3 pThe remediation roadmap is structured in three waves (high,medium, and low priority actions). The initial assignment focuses primarily onthe high-priority actions, with possible extensions to support subsequentphases.br/ /p h3Mission Context /h3 pFollowing an inspection, we are strengthening our bDataIntegrity framework /b for its global LIMS environment.br/ /p h3Department /h3 pData Integrity / CSV / LIMS environment supporting multiplequality, business, and digital organizations.br/ /p h3Team Stakeholders /h3 pThe contingent worker will collaborate with several teams,including:br/ /p ulliCSV/QAteambr/ /liliBusinessstakeholdersbr/ /liliDigitalTechnology teambr/ /liliLIMSteambr/ /liliDataIntegrity Leadbr/ /liliMultipledepartments using LIMS across Belgium and Switzerlandbr/ /li /ul pThe LIMS platform is used by approximately ten departmentsacross Belgium and Switzerland, requiring solutions and procedures that can beapplied consistently across sites.br/ /p h3Key Responsibilities /h3 ulliLeadthe execution of a Data Integrity remediation plan comprisingapproximately 40 actionsbr/ /liliDefineactions, owners, priorities, and timelinesbr/ /liliCoordinateremediation activities across multiple teamsbr/ /liliExecutepart of the remediation activities directlybr/ /liliDefineand implement a global Audit Trail Review SOPbr/ /liliCoverboth routine and periodic audit trail reviewsbr/ /liliPerforma comprehensive review of user roles and system privilegesbr/ /liliAssessand document access rights justificationsbr/ /liliIdentifyinappropriate privileges and define corrective actionsbr/ /liliPerformor review Data Integrity Risk Assessmentsbr/ /liliDevelopand review Data Flow Diagramsbr/ /liliOrganizeand facilitate workshops with stakeholdersbr/ /liliMonitorprogress and provide status reportingbr/ /liliDriveissue resolution and remediation completionbr/ /li /ul h3Typical Day /h3 ulliFollowingup on remediation actions and deadlinesbr/ /liliCoordinatingwith QA, CSV, Business, Digital Technology, and LIMS teamsbr/ /liliWritingor reviewing Data Integrity documentation and SOPsbr/ /liliReviewinguser roles and privilegesbr/ /liliFacilitatingworkshops and working sessionsbr/ /liliResolvingroadblocksbr/ /liliExecutinghands-on remediation activitiesbr/ /liliReportingprogress to stakeholdersbr/ /li /ul h3Requirements /h3 h3Candidate Profile /h3 pExperienced bData Integrity and CSV professional /b capable of combining leadership, cross-functional coordination, and hands-onexecution.br/ /p pThis role is not suitable for a profile with onlytheoretical knowledge or purely project management experience.br/ /p h3Must-Have /h3 ulliStrongData Integrity experience within a pharmaceutical or regulated environmentbr/ /liliGoodknowledge of Data Integrity regulatory expectationsbr/ /liliExperiencewith Audit Trail Reviewsbr/ /liliExperiencedefining continuous and periodic review processesbr/ /liliExperiencewriting and implementing SOPsbr/ /liliKnowledgeof user roles, privilege matrices, and access managementbr/ /liliExperienceconducting Data Integrity Risk Assessmentsbr/ /liliExperiencewith Data Flow Diagramsbr/ /liliGoodunderstanding of CSV principlesbr/ /liliExperienceleading remediation programsbr/ /liliAbilityto execute remediation activities directlybr/ /liliStrongcommunication and stakeholder management skillsbr/ /liliAbilityto collaborate across multiple teams and departmentsbr/ /li /ul h3Nice-to-Have /h3 ulliHands-onexperience with LabWarebr/ /liliExperiencemanaging inspection observations and remediation activitiesbr/ /liliExperiencewithin Belgium
- or Switzerland-based pharmaceutical organizationsbr/ /li /ul