Global Lead Auditor, Dublin

Global Lead Auditor

Full Time Permanent, CityWest The Role

The Global Quality Lead is responsible for providing strategic direction, governance, and leadership across all global Quality operations. This role ensures consistent implementation of the Global Quality Management System (QMS), drives compliance with all applicable GDP/GMP/GxP regulations, and partners with regional and functional teams to elevate Quality standards globally. The position requires strong cross functional influence, exceptional communication skills, and the ability to lead quality initiatives across multiple regions, cultures, and business units. The Global Audit Lead provides independent assurance on compliance, quality systems and risk management, and leads both the internal and external audit function. The role is a key advisor to senior leadership and the Audit Committee on regulatory, quality and operational risk.Responsibilities

Global Audit Strategy&Governance

Define and maintain the global audit strategy covering GxP and related quality systems. Establish global audit policies, procedures and methodologies aligned to EMA, ICH, FDA, MHRA and other regulatory requirements. Ensure alignment of audit activities with enterprise risk management and quality management systems (QMS).Oversee global risk‑based audit planning across all GxP activities. Identify cost savings, operational&business process improvements. Support the maintenance of global quality procedures and policies. Implement global quality agreement templates to support vendor management process. Support audit findings relating to global quality procedures and policies.

Regulatory&Standards Oversight

Ensure audit frameworks reflect applicable GxP requirements and ISO standards. Monitor regulatory trends and emerging compliance risks. Monitor regulatory changes and guide regions on the implementation of new or updated requirements. Provide expert oversight of compliance issues and regulatory inspection readiness.

Leadership&Functional Oversight

Lead and develop the global audit function, including direct management of the Internal and External Audit Leads. Coordinate the review and management of audit findings across global QA functions, facilitating cross‑functional input to determine acceptance or rejection of findings and driving updates to global SOPs and quality systems as required.Provide direction, challenge and support to audit teams across regions and functions. Foster a strong culture of quality, compliance and continuous improvement.

Assurance&Risk Management

Provide independent assurance on the effectiveness of quality systems, internal controls and regulatory compliance. Identify systemic issues and cross‑functional risks across global operations. Drive continuous improvement initiatives in governance, quality and control frameworks.

Reporting&Stakeholder Engagement

Report global audit outcomes, trends and key risks to executive leadership and the Audit Committee. Act as a senior partner to the leadership team and foster a culture of Continuous Improvement. Oversee remediation of global audit findings and management action plans.

Strategic Leadership

Recruit, mentor and develop auditors across multiple regions. Promote cross‑regional collaboration and knowledge‑sharing. Ensure regional and site leaders understand and accept responsibility for remediation. Maintain Uniphi communication and presence.

Key Skills and Experience

Essential:

Extensive experience in regulated pharmaceutical or life sciences environments. Deep expertise in GxP regulations (GMP, GDP, GCP) and global regulatory frameworks. Strong knowledge of ISO standards and quality management systems. Proven leadership of global audit or quality assurance functions. Ability to engage credibly with regulators, senior leadership and audit committees. International travel will be required to support global audits, site visits, training, supplier oversight and cross‑regional collaboration.Desirable:

Quality or regulatory qualifications (e.g. QP, RQAP, ISO Lead Auditor). Experience managing regulatory inspections or major compliance programmes.

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