Quality Assurance Manager

A leading healthcare group is seeking an experienced Quality Manager to oversee and continually improve its Quality Management System (QMS) in the GDP environment. This is an exciting opportunity for a driven quality professional to play a key role in maintaining excellence in patient care, regulatory compliance, and organisational performance.

Reporting to the Head of Quality, the Quality Manager will lead the Quality team and ensure that all activities comply with relevant EU Directives.

Join this inclusive, collaborative team with a passion for patient outcomes.

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• Lead and support non‑conformance, complaint and change‑control investigations.
  
• Review and approve complaints, non‑conformances, and change‑control documentation.
  
• Prepare quality reports, KPIs, and updates for senior management.
  
• Liaise with insurers, legal teams, and international partners as required.
  
• Support Serious Adverse Event investigations.
  

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• Ensure full compliance with WDA conditions, GDP guidelines, and applicable legislation.
  
• Oversee authorised activities, documentation accuracy, and quality of records.
  
• Manage all HPRA inspections and licence variation applications.
  

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• Lead the internal audit programme and manage audit resources.
  
• Prepare audit checklists, schedules, and notifications.
  
• Report, track and trend audit findings.
  

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• Manage controlled documentation and SOP implementation.
  
• Ensure timely review and publication of procedures.
  
• Maintain QMS registers and compliance documentation.
  
• Day‑to‑day management of the Quality team including performance reviews and training.
  
• Motivate, support, and develop team members.
  
• Manage annual leave and resource allocation.
  

The role also includes acting as Responsible Person for a wholesale distribution facility operating under a Wholesale Distribution Authorisation (WDA). Possible option to train and certify as an RP in the course of the role.

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• Degree in quality, science, or related field.
  
• Minimum 3 years’ experience in a supervisory or management role in GDP Quality environment.
  
• Strong leadership, communication, and people management skills.
  
• High attention to detail and commitment to accuracy.
  
• Responsible Person (RP) certification. (Training will be provided to achieve RP status)
  
• Experience in the healthcare or pharmaceutical sector.
  
• Integrity, accountability, and strong personal leadership.
  
• Collaborative, team‑focused mindset. xcfaprz
  
• Excellent communication and conflict‑management skills.