Data integrity remediation plan lead
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What is the mission about?
SEE JD
Job Description
The 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.
Mission Context
Following an inspection, we are strengthening our DataIntegrity framework for its global LIMS environment.
Department
Data Integrity / CSV / LIMS environment supporting multiplequality, business, and digital organizations.
Team & Stakeholders
The contingent worker will collaborate with several teams,including:
- CSV/QAteam
- Businessstakeholders
- DigitalTechnology team
- LIMSteam
- DataIntegrity Lead
- Multipledepartments using LIMS across Belgium and Switzerland
The LIMS platform is used by approximately ten departmentsacross Belgium and Switzerland, requiring solutions and procedures that can beapplied consistently across sites.
Key Responsibilities
- Leadthe execution of a Data Integrity remediation plan comprisingapproximately 40 actions
- Defineactions, owners, priorities, and timelines
- Coordinateremediation activities across multiple teams
- Executepart of the remediation activities directly
- Defineand implement a global Audit Trail Review SOP
- Coverboth routine and periodic audit trail reviews
- Performa comprehensive review of user roles and system privileges
- Assessand document access rights justifications
- Identifyinappropriate privileges and define corrective actions
- Performor review Data Integrity Risk Assessments
- Developand review Data Flow Diagrams
- Organizeand facilitate workshops with stakeholders
- Monitorprogress and provide status reporting
- Driveissue resolution and remediation completion
Typical Day
- Followingup on remediation actions and deadlines
- Coordinatingwith QA, CSV, Business, Digital Technology, and LIMS teams
- Writingor reviewing Data Integrity documentation and SOPs
- Reviewinguser roles and privileges
- Facilitatingworkshops and working sessions
- Resolvingroadblocks
- Executinghands-on remediation activities
- Reportingprogress to stakeholders
Requirements
Candidate Profile
Experienced Data Integrity and CSV professional capable of combining leadership, cross-functional coordination, and hands-onexecution.
This role is not suitable for a profile with onlytheoretical knowledge or purely project management experience.
Must-Have
- StrongData Integrity experience within a pharmaceutical or regulated environment
- Goodknowledge of Data Integrity regulatory expectations
- Experiencewith Audit Trail Reviews
- Experiencedefining continuous and periodic review processes
- Experiencewriting and implementing SOPs
- Knowledgeof user roles, privilege matrices, and access management
- Experienceconducting Data Integrity Risk Assessments
- Experiencewith Data Flow Diagrams
- Goodunderstanding of CSV principles
- Experienceleading remediation programs
- Abilityto execute remediation activities directly
- Strongcommunication and stakeholder management skills
- Abilityto collaborate across multiple teams and departments
Nice-to-Have
- Hands-onexperience with LabWare
- Experiencemanaging inspection observations and remediation activities
- Experiencewithin Belgium- or Switzerland-based pharmaceutical organizations
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