Data integrity remediation plan lead

The remediation roadmap is structured in three waves (high medium and low priority actions). The initial assignment focuses primarily on the high-priority actions with possible extensions to support subsequent phases.

Mission Context

Following an inspection we are strengthening our Data Integrity framework for its global LIMS environment.

A remediation plan containing approximately 40 actions has already been defined. The selected contingent worker will be responsible both for driving the overall remediation plan and executing a number of remediation activities directly.

This is therefore a lead role requiring both strategic coordination and hands-on execution.

Department

Data Integrity / CSV / LIMS environment supporting multiple quality business and digital organizations.

Team & Stakeholders

The contingent worker will collaborate with several teams including:

• CSV/QA team
  
• Quality team
  
• Business stakeholders
  
• Digital Technology team
  
• LIMS team
  
• Data Integrity Lead
  
• Multiple departments using LIMS across Belgium and Switzerland
  

The LIMS platform is used by approximately ten departments across Belgium and Switzerland requiring solutions and procedures that can be applied consistently across sites.

Key Responsibilities

• Lead the execution of a Data Integrity remediation plan comprising approximately 40 actions
  
• Define actions owners priorities and timelines
  
• Coordinate remediation activities across multiple teams
  
• Execute part of the remediation activities directly
  
• Define and implement a global Audit Trail Review SOP
  
• Cover both routine and periodic audit trail reviews
  
• Perform a comprehensive review of user roles and system privileges
  
• Assess and document access rights justifications
  
• Identify inappropriate privileges and define corrective actions
  
• Perform or review Data Integrity Risk Assessments
  
• Develop and review Data Flow Diagrams
  
• Organize and facilitate workshops with stakeholders
  
• Monitor progress and provide status reporting
  
• Drive issue resolution and remediation completion
  

Typical Day

• Following up on remediation actions and deadlines
  
• Coordinating with QA CSV Business Digital Technology and LIMS teams
  
• Writing or reviewing Data Integrity documentation and SOPs
  
• Reviewing user roles and privileges
  
• Conducting risk assessments
  
• Facilitating workshops and working sessions
  
• Resolving roadblocks
  
• Executing hands-on remediation activities
  
• Reporting progress to stakeholders
  

Candidate Profile

Experienced Data Integrity and CSV professional capable of combining leadership cross-functional coordination and hands-on execution.

This role is not suitable for a profile with only theoretical knowledge or purely project management experience.

Must-Have

• Strong Data Integrity experience within a pharmaceutical or regulated environment
  
• Good knowledge of Data Integrity regulatory expectations
  
• Experience with Audit Trail Reviews
  
• Experience defining continuous and periodic review processes
  
• Experience writing and implementing SOPs
  
• Knowledge of user roles privilege matrices and access management
  
• Experience conducting Data Integrity Risk Assessments
  
• Experience with Data Flow Diagrams
  
• Good understanding of CSV principles
  
• Experience leading remediation programs
  
• Ability to execute remediation activities directly
  
• Strong communication and stakeholder management skills
  
• Ability to collaborate across multiple teams and departments
  
• Professional English
  

Nice-to-Have

• Experience supporting global LIMS environments
  
• Hands-on experience with LabWare
  
• Experience managing inspection observations and remediation activities
  
• International or multi-site experience
  
• Experience within Belgium- or Switzerland-based pharmaceutical organizations
  
• Professional French
  

Languages

• English required
  
• French is considered an asset