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Details
Senior Audit & Compliance Specialist
| Reference: | SCA015782 | Location: |
Galway |
| Qualification: | Degree | Experience: | 5-7 Years |
| Job Type: | Permanent | Salary: | 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.
- 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.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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