Data Integrity Lead
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
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