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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Audit & Compliance Specialist


Reference:SCA015782 Location: Galway
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA RA Engineer, QA Specialist, QA Supervisor, Quality Auditor, Quality Manager, Quality Specialist, Quality Systems Lead, Quality Systems Specialist

Senior Audit & Compliance Specialist
This senior position sits within a global healthcare leader’s high-growth Diagnostics business unit. Reporting to the Audit & Inspection Readiness Manager, the successful candidate will lead the supplier audit lifecycle and maintain a state of continuous inspection readiness across multi-site manufacturing networks.

Key Responsibilities

  • Audit Lifecycle Leadership: Independently plan, execute, and report on global supplier, internal, and external quality system audits.
  • Compliance: Ensure all Quality Management System (QMS) and supplier activities strictly comply with global corporate standards and external regulations (MDSAP, MDR/IVDR, and cGMP).
  • Data-Driven Oversight: Maintain the supplier audit schedule and track metrics; analyze and trend audit findings to proactively identify and mitigate systemic supply chain risks.
  • Inspection Readiness & Hosting: Prepare sites for external regulatory inspections and corporate audits. Lead front-room/back-room logistics, manage document reviews, and coach subject matter experts (SMEs).
  • Complex Problem Solving: Apply critical thinking to resolve legacy/aged CAPAs, complex complaint investigations, and field actions.
Requirements & Qualifications
  • Education: Level 8 degree in Life Sciences, Engineering, Quality Assurance, or a related technical discipline.
  • Experience: 5+ years of quality or regulatory experience within a highly regulated manufacturing environment (Medical Devices / Diagnostics preferred).
  • Technical Expertise: Proven track record of independently leading supplier audits and reviewing Technical Documentation for MDR/IVDR compliance.
  • Travel Availability: Ability to travel 40–50% globally to conduct on-site supplier assessments.
For more information please contact Sinéad Cullen on +353879500821 or [email protected]