Overview
Global Quality Auditor Jobs in Ireland at Blackfield Associates
Title: Global Quality Auditor
Company: Blackfield Associates
Location: Ireland
Blackfield Associates is partnered with a leading pharmaceutical organisation in the search for a Global Lead Auditor that will be remote based across UK and Ireland.
As the Global Lead Auditor, you will be responsible for providing strategic direction, governance, and leadership across all global Quality operations. You will ensure the consistent implementation of the Global Quality Management System, drive compliance with applicable GDP, GMP, and GxP regulations, and partner with regional and functional teams to elevate quality standards globally. This role will also provide independent assurance on compliance, quality systems, and risk management, while leading both the internal and external audit function.
Key responsibilities within the position will be:
- Define and maintain the global audit strategy, policies, and methodologies, ensuring alignment with EMA, ICH, FDA, MHRA, ISO standards, and enterprise risk management frameworks.
- Lead global audit planning and oversight across all GxP activities, including the management and remediation of audit findings, updates to global SOPs, and support for quality agreements and vendor management.
- Provide leadership and development for the global audit function, including direct management of internal and external audit leads, while driving continuous improvement across global QA operations.
- Report audit outcomes, trends, and key risks to executive leadership and the Audit Committee, while promoting cross-regional collaboration, knowledge-sharing, and accountability for remediation.
The correct candidate for this opportunity will have extensive experience within regulated pharmaceutical or life sciences environments, with deep expertise in GxP regulations including GMP, GDP, and GCP, as well as broader global regulatory frameworks. You will have strong knowledge of ISO standards and quality management systems, alongside proven leadership of global audit or quality assurance functions. The successful candidate will be confident engaging credibly with regulators, senior leadership, and audit committees, and will be prepared to travel internationally to support global audits, site visits, training, supplier oversight, and cross-regional collaboration. Desirable experience would include quality or regulatory qualifications such as QP, RQAP, or ISO Lead Auditor, as well as experience managing regulatory inspections or major compliance programmes.
