Senior Quality System Manager – GMP, ISO 9001 & CAPA

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

Job summary

CareerWise Recruitment in Ireland is seeking a senior Quality Manager for a Cork-based pharmaceutical manufacturer. The role leads the site QMS, ensuring GMP compliance and driving continuous improvement across operations.

You will oversee audits, regulatory inspections, CAPAs, deviations and product releases, and lead quality training while collaborating with customers, suppliers and commercial teams. Extensive leadership and chemistry background required.

Qualifications

• Proven leadership in quality at GMP/manufacturing sites.
• Strong knowledge of GMP/ISO standards and validation.
• Excellent communication and problem-solving abilities.

Responsibilities

• Lead and maintain the site Quality Management System (QMS).
• Ensure GMP, ISO 9001 and other regulatory standards are met.
• Manage audits, customer inspections and regulatory visits.
• Oversee CAPAs, deviations, change controls and quality investigations.
• Approve quality documentation, validation activities and product releases.
• Support development of new product specifications and customer requirements.
• Lead quality training programmes and ensure site-wide compliance.
• Drive continuous improvement metrics and quality performance.
• Provide quality support to customers, suppliers and commercial teams.

Skills

Quality leadership

Audits & inspections

Regulatory compliance

Problem solving

Education

Chemistry degree

Job description

CareerWise Recruitment in Ireland is seeking a senior Quality Manager for a Cork-based pharmaceutical manufacturer. The role leads the site QMS, ensuring GMP compliance and driving continuous improvement across operations.

You will oversee audits, regulatory inspections, CAPAs, deviations and product releases, and lead quality training while collaborating with customers, suppliers and commercial teams. Extensive leadership and chemistry background required.