Lead Auditor, Quality Compliance, Tullamore

Lead Auditor, Quality Compliance will join the Corporate Audit team and lead, coordinate and perform corporate audits of the Quality Management System (QMS) across more than 15 design, manufacturing and distribution facilities. Responsibilities

Use evidence‑based investigation techniques to confirm that global QMS policies, procedures and regulatory requirements are consistently met. Prepare a formal written report for the audit program head, including audit methodology, observations, recommendations, site classification and an executive summary for senior leadership.Identify problematic areas during audits and work with site representatives to develop and implement improvement actions. Support site inspection readiness through corporate audits, high‑risk CAPA reviews, mock inspection role‑playing and SME/auditee coaching. Collaborate with the audit program head to refine audit processes and systems for greater efficiency while maintaining quality control.Facilitate global implementation of policies at divisional, site and third‑party levels through auditing, education, communication and enforcement. Lead or participate in required corporate audits and ensure timely finalisation of audit reports. Recommend follow‑up or re‑audit work and participate in continuous improvement initiatives as a global quality representative.Provide review and support to individuals, working groups or sites on technical expertise in the audit area. Continuously develop personal and technical skills to stay within the scope of the role and support a culture of continuous improvement. Coach and train other team members across functions and geographies, demonstrating technical expertise and leadership.Perform other related duties as expected. Qualifications

Minimum 15 years of auditing experience in quality, manufacturing or engineering, or equivalent education and experience. Lead auditor experience for GMP, GDP, GLP or GCP audits in multinational medical device or pharmaceutical companies. Hands‑on GMP, GDP, GCP, GLP or ISO 14971 implementation experience; intimate knowledge of 21CFR Part820, ISO13485, EU Medical Device Regulation and MDSAP.Background in quality/operations GMP work at a medical device or pharmaceutical manufacturing site, or equivalent in QS/QA/QC/OPS or technical management. Experience auditing technical files for conformance with EU regulations for CE‑marked medical devices. Experience with regulatory agencies (e.g., U.S. FDA, MHRA, TGA, Health Canada, SFDA, ANVISA, U.S. state agencies) or Notified Bodies (BSI, NSAI, LRQA, TüV).Specialised technical expertise in one or more of the following: sterilisation, microbiology, manufacturing facility engineering and design, statistical analysis, process validation, regulatory compliance, clinical trials, computer systems validation, quality systems or data security. Working knowledge of multiple languages and willingness to travel up to 50% internationally.Lead audit experience for materials suppliers, manufacturing sites, distribution centres or laboratories. Bachelor’s degree in engineering, sciences or a relevant technical field; master’s degree preferred. Formal auditor certification from a recognised body (e.g., IRCA, ASQ CQA, BSI, Exemplar Global).Strong collaboration skills and experience working in a matrix environment.

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