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
  

Requirements

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