GxP Documentation Lead – Compliance & Archiving

Sanofi; Waterford; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Sanofi Waterford is seeking a Documentation Specialist to join our Site Documentation Management team. You will manage the full GxP documentation lifecycle, ensuring accuracy, traceability, and compliance across CMS and archiving systems.

You will collaborate with cross-functional teams to reflect business needs, support audits, and maintain alignment with global procedures and regulatory requirements. Fluency in English is required.

Qualifications

• Experience in documentation management within a GxP environment.
• Familiarity with quality and documentation management systems is essential.
• Understanding regulatory standards and writing rules is required.

Responsibilities

• Manage the complete GxP documentation lifecycle, including creation, revision, and obsolescence.
• Collaborate across departments to ensure content reflects business needs and processes.
• Ensure documentation compliance with regulatory requirements and company standards.
• Maintain lean documentation by removing redundancies and duplication.
• Review documentation for accuracy, completeness, and grammar.
• Collect, prioritize, and manage documentation change requests to keep content current.
• Control document distribution and access according to classification levels.
• Support audits and inspections by ensuring documents are readily retrievable.
• Establish and maintain documentation systems and advise stakeholders on updates.

Skills

Documentation management

Quality assurance

Regulatory compliance

GxP experience

Tools

Documentation Management Systems

Job description

Sanofi Waterford is seeking a Documentation Specialist to join our Site Documentation Management team. You will manage the full GxP documentation lifecycle, ensuring accuracy, traceability, and compliance across CMS and archiving systems.

You will collaborate with cross-functional teams to reflect business needs, support audits, and maintain alignment with global procedures and regulatory requirements. Fluency in English is required.