Overview:

This is a senior site-based quality role with responsibility for managing and developing the Quality Management System to ensure full GxP compliance. As QA Systems Manager, you’ll act as a key member of the Quality leadership team and take ownership of site-wide quality processes, with particular focus on data integrity, validation oversight, documentation, and continuous improvement of systems that support GMP/GDP operations.

You’ll also work closely with colleagues across Quality, Validation, Manufacturing, and IT, providing compliance guidance and driving a strong quality culture.

Key Responsibilities:

• Lead the development, maintenance and ongoing compliance of the site QMS in line with GxP requirements
• Act as site lead for data integrity, ensuring systems and processes support secure, traceable and compliant data management
• Oversee the validation master plan and provide QA oversight for validation-related activities across the site
• Manage and improve key quality systems including change control, CAPA, deviations, document control and training compliance
• Provide input and quality guidance on GxP-related investigations, audits and continuous improvement initiatives
• Deliver training and coaching across departments to reinforce best practice in quality and compliance
• Maintain oversight of system-based metrics and reporting to support inspection readiness and internal performance monitoring
• Contribute to Quality leadership team projects and initiatives to enhance overall site compliance

Ideal Experience:

• Extensive experience in pharmaceutical QA, with a strong understanding of GMP and GDP
• Proven track record in managing QMS elements, including validation, documentation, and data integrity
• Experience supporting inspections and audits, both internal and external
• Excellent communication and stakeholder engagement skills across cross-functional teams
• Familiarity with electronic quality systems (such as LIMS, TrackWise or Documentum) is advantageous
• Scientific or technical background preferred