Senior Quality & Compliance Lead - GMP & Regulatory

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

Job summary

Careerwise Recruitment is assisting a rapidly growing pharma manufacturer in Ireland to appoint an experienced Head of Quality & Compliance. You will lead the site's QMS, drive regulatory excellence, and act as primary quality representative during audits.

In this senior role you will partner with senior leadership to shape quality strategy, ensure GMP/ISO 9001 compliance, and deliver improvements across manufacturing, validation, documentation, and release activities.

Qualifications

• Degree qualified in Chemistry, Pharmaceutical Science, Life Sciences, or related discipline.
• Minimum 5 years' experience in pharmaceutical, biopharmaceutical, or GMP-regulated manufacturing.
• Experience leading quality teams and quality systems.

Responsibilities

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

Skills

Leadership

Quality management

Regulatory compliance

CAPA management

Audit readiness

Education

Chemistry / Pharmaceutical Science / Life Sciences degree

Job description

Careerwise Recruitment is assisting a rapidly growing pharma manufacturer in Ireland to appoint an experienced Head of Quality & Compliance. You will lead the site's QMS, drive regulatory excellence, and act as primary quality representative during audits.

In this senior role you will partner with senior leadership to shape quality strategy, ensure GMP/ISO 9001 compliance, and deliver improvements across manufacturing, validation, documentation, and release activities.