Quality System Manager

ARTO; Leinster; On-site; EUR 90,000 - 120,000; Full time

Job summary

ARTO is seeking an experienced Quality Systems Manager to lead and continuously improve our global 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 a small Quality Systems team and embed risk-based quality practices into business processes and projects, while overseeing deviations, CAPA, change control and

Qualifications

• A degree in Life Sciences or related discipline.
• 8+ years' experience in pharmaceutical or other regulated environment.
• 3+ years' experience in a Quality Management/QMS role.
• Strong hands-on experience with deviations, CAPA, change control and document management.
• Experience supporting regulatory inspections and audits.
• Strong knowledge of GxP, EU/FDA/ICH requirements and quality standards.

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 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 completed.
• Manage, coach and develop the Quality Systems team.
• Promote a culture of quality, compliance and continuous improvement.

Skills

Quality leadership

GxP knowledge

Regulatory compliance

Cross-functional influence

Education

Life Sciences degree

Job description

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.

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