Quality System Manager

Quality System Manager (People manager)

Location: Ireland

Company: Pharmaceutical

We are looking for an experienced Quality Systems Manager to lead the effective operation and continuous improvement of our global Quality Management System (QMS) within a GxP-regulated environment.

You will combine quality expertise, operational leadership and cross-functional influence to ensure the QMS remains effective, compliant and inspection-ready across the organisation. You will also lead and develop a small Quality Systems team.

Key responsibilities

• Lead the operation and continuous improvement of the global QMS.
• Ensure consistent application of quality processes across functions and sites.
• Oversee core QMS activities including deviations, CAPA, change control and document management .
• Monitor quality metrics and trends, identifying risks and improvement opportunities.
• Maintain audit and regulatory inspection readiness and support inspection activities.
• Drive a practical, risk-based approach to quality and ensure appropriate escalation and follow-up.
• Partner with stakeholders to embed GxP and quality requirements into business processes and projects.
• Lead quality governance activities and ensure actions are effectively managed through to completion.
• Manage, coach and develop the Quality Systems team.
• Promote a strong culture of quality, compliance and continuous improvement.

Candidate Profile:

• A degree in Life Sciences or a related discipline.
• 8+ years' experience in pharmaceutical or another suitably regulated environment.
• 3+ years' experience in a Quality Management/QMS role.
• Strong hands-on experience with deviations, CAPA, change control, document management and audits.
• Experience supporting regulatory inspections and internal/external audits.
• Strong knowledge of GxP, EU/FDA/ICH requirements and relevant quality standards .
• Practical experience applying risk-based quality management and using QMS data to drive decisions.
• Experience working in a global or multi-site organisation.
• Experience leading and developing people.
• Fluent English is essential.

Desirable

Experience with digital quality transformation, electronic QMS implementations or system upgrades would be advantageous. Additional European languages are a plus.