QC Stability Manager

Your mission

The Stability Manager is responsible for managing all aspects of the stability program across all projects and UK and Ireland sites, including initiating and managing stability studies, protocol development and maintenance, data monitoring, trending and reporting.

Job Description

Major Activities

• Designs, coordinate, and execute stability studies for clinical and commercial gene therapy products according to regulatory guidelines and company protocols.
• Generate stability reports by applying analytical testing expertise to ensure scientific and technical excellence. Utilize statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.
• Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents (as required).
• The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.
• Drives continuous improvement activities for the stability programs.
• Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.
• Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other appli