Site Quality Manager & Regulatory Affairs Lead

Site Quality Manager & Regulatory Affairs Lead

Cork | Permanent | Onsite

We are working with an established international manufacturing organisation to recruit a Site Quality Manager & Regulatory Affairs Lead to oversee quality management and regulatory activities at its Cork site.

This is a leadership role combining Quality Management, regulatory compliance, auditing and continuous improvement, with responsibility for maintaining a robust site quality system and supporting alignment with wider group standards.

Key Responsibilities

• Lead the site’s Quality Management and Regulatory Affairs function.

• Maintain, develop and audit the site’s Quality Management System.

• Ensure compliance with ISO 9001 and relevant regulatory requirements.

• Develop and implement processes supporting product quality and regulatory compliance.

• Coach and support employees on quality and regulatory matters.

• Monitor quality performance, defects and corrective/preventive actions.

• Plan and conduct internal and external audits.

• Act as the key quality representative for customers, auditors and other stakeholders.

• Support document control and change management.

• Develop and monitor quality KPIs and continuous improvement initiatives.

• Collaborate with Quality teams across international sites to harmonise standards and processes.

• Support cross-site audits and group quality strategy development.

• Lead local quality initiatives and drive a culture of quality and accountability.

Requirements

• Engineering qualification or equivalent technical education.

• Strong knowledge of ISO 9001 and relevant regulatory requirements.

• Proven experience in production or manufacturing quality management.

• Experience managing or supporting internal and external audits and certification activities.

• Strong knowledge of quality tools, methodologies and continuous improvement.

• Experience with corrective and preventive action processes.

• Strong analytical and problem-solving skills.

• Excellent communication, coaching and stakeholder management skills.

• Experience in conflict resolution, mediation or facilitating challenging discussions.

• Ability to work independently and lead local quality initiatives.

What’s on Offer

• Site leadership opportunity with responsibility for Quality and Regulatory Affairs.

• Opportunity to influence quality strategy and continuous improvement.

• International exposure and collaboration across multiple sites.

• Strong involvement in quality systems, audits and regulatory compliance.

• Opportunity to develop and lead a local quality function.

• Competitive salary and benefits package.

• Professional development and career progression opportunities.

Apply now to discuss this opportunity in confidence.