Data Integrity & CSV Program Manager

Location: Lyon, France
Start: Approximately 1-2 months
Duration: 12 months
Language: Fluent French required

Role Overview

We are seeking an experienced Data Integrity & CSV Program Manager to lead a large-scale Data Integrity programme within a pharmaceutical manufacturing environment.

The programme will involve the upgrade, configuration and validation of potentially hundreds of computerized systems, with a strong focus on Data Integrity and GxP compliance. The Program Manager will coordinate activities across internal teams, contractors and multiple external consulting partner.

Key Responsibilities

• Lead the overall delivery of a complex, multi-year Data Integrity and computerized systems upgrade programme.
• Coordinate the upgrade, configuration and validation of a large portfolio of GxP computerized systems.
• Develop and manage project plans, priorities, resources, timelines and key deliverables.
• Coordinate cross-functional teams including Quality, IT, Engineering, Validation and Operations.
• Manage and align internal employees, contractors and consultants from multiple external organisations.
• Ensure computerized systems are appropriately assessed and validated with a strong focus on Data Integrity.
• Provide oversight of CSV/validation and remediation activities.
• Track programme progress, risks, dependencies and remediation actions.
• Provide clear reporting and communication to senior stakeholders.
• Support compliant and sustainable implementation of system upgrades across the site.

Requirements

• Strong experience leading large, complex projects or programmes within pharmaceutical, biotech or another GxP-regulated environment.
• Extensive knowledge of Computer System Validation (CSV) and Data Integrity.
• Hands-on understanding of computerized system configuration and validation.
• Strong knowledge of software-related issues; direct experience in software development and/or software configuration would be highly advantageous.
• Experience managing large portfolios of system upgrades, remediation or validation activities.
• Proven ability to coordinate large cross-functional and multi-vendor teams.
• Strong stakeholder management, organisation and communication skills.
• Fluent French essential.
• Must be willing and able to be based in the Lyon area for an extended period