Senior Quality & Compliance Leader - GMP & ISO 9001

CareerWise Recruitment; Fermoy; On-site; EUR 90,000 - 120,000; Full time

Job summary

CareerWise Recruitment is assisting a leading Irish manufacturer in appointing an experienced Quality Compliance Manager to lead site quality operations and drive a culture of excellence, compliance, and continuous improvement.

This senior role shapes quality strategy, influences site performance, and ensures GMP and regulatory compliance across the business, supporting future growth and innovation.

Qualifications

• Degree required in Chemistry, Pharmaceutical Science, Life Sciences or related.
• Minimum 5 years in pharmaceutical, biopharma or GMP manufacturing environments.

Responsibilities

• Lead and continuously improve the site's Quality Management System (QMS).
• Ensure ongoing GMP and ISO 9001 compliance and meet customer requirements.
• Act as site lead for regulatory inspections, customer audits, and certification assessments.
• Drive CAPAs, deviations, non-conformances, change controls, and root cause investigations.
• Review and approve quality documentation, validation activities, specifications, and product release.
• Partner with production, engineering, technical, and commercial teams to support new products and customer requirements.

Skills

Quality leadership

GMP compliance

Regulatory compliance

CAPA management

Education

Degree in Chemistry, Pharmaceutical Science, Life Sciences

Job description

CareerWise Recruitment is assisting a leading Irish manufacturer in appointing an experienced Quality Compliance Manager to lead site quality operations and drive a culture of excellence, compliance, and continuous improvement.

This senior role shapes quality strategy, influences site performance, and ensures GMP and regulatory compliance across the business, supporting future growth and innovation.